Page last updated: 2024-11-11

dexlansoprazole

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Description

Dexlansoprazole: The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID9578005
CHEMBL ID1201863
CHEBI ID135931
SCHEMBL ID44975
MeSH IDM0525973

Synonyms (75)

Synonym
nsc-758710
t-168390
tak-390
lansoprazole, (r)-
lansoprazole r-form
CHEMBL1201863
(r)-lansoprazole
kapidex
dexilant
dexlansoprazole
CHEBI:135931
D08903
dexilant (tn)
dexlansoprazole (inn/usan)
138530-94-6
unii-uye4t5i70x
1h-benzimidazole, 2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-
(+)-2-((r)-{(3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl}sulfinyl)-1h-benzimidazole
2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1h-benzimidazole
uye4t5i70x ,
nsc 758710
dexlansoprazole [usan:inn]
t 168390
tak 390
S4099
dexilant solutab
PB33188
dexlansoprazole [usan]
dexlansoprazole [vandf]
lansoprazole r-form [mi]
dexlansoprazole [inn]
dexlansoprazole [who-dd]
dexlansoprazole [orange book]
(+)-2-((r)-((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzimidazole
dexlansoprazole [mart.]
gtpl5487
(+)-lansoprazol
2-[(r)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methane}sulfinyl]-1h-1,3-benzodiazole
CCG-213301
HY-13662B
(r)-(+)2-([3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methylsulfinyl)-1h-benzimidazole
(r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]benzimidazole
r-(+)-lansoprazole
2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole
(r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1h-benzimidazole
(r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]-1h-benzimidazole
(r)-2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl]benzimidazole
SCHEMBL44975
2-[(r)-[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methylsulfinyl]-1h-benzimidazole
r-lansoprazole
AKOS025290765
AC-26449
AB01563023_01
AB01563023_02
(r)-2-(((3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl)methyl)sulfinyl)-1h-benzo[d]imidazole
HMS3652C14
mfcd13196699
SW219466-1
DB05351
bdbm50247930
AS-18086
Q5268339
AMY25226
NCGC00386267-03
1h-benzimidazole, 2-[(r)-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-
dexlansoprazol
lansoprazole, r isomer
r lansoprazole
dexlansoprazole (mart.)
lansoprazole, r-isomer
dexlansoprazoledelayed release
dexlansoprazolum
dexlansoprazole|lansoprazole
r-isomer lansoprazole
a02bc06

Research Excerpts

Overview

Dexlansoprazole (DLP) is a heterocyclic compound containing benzimidazole moiety and a proton pump inhibitor used to treat gastroesophageal reflux disease. It is a new PPI and lacks of evidence in support of a role in H.

ExcerptReferenceRelevance
"Dexlansoprazole (DLP) is a heterocyclic compound containing benzimidazole moiety and a proton pump inhibitor used to treat gastroesophageal reflux disease."( Deciphering the nature of binding of dexlansoprazole with DNA: Biophysical and docking approaches.
Bodapati, ATS; Kandikonda, L; Madku, SR; Ragaiahgari, SR; Sahoo, BK, 2022
)
1.72
"Dexlansoprazole is a new proton pump inhibitor (PPI) with a dual delayed-release system. "( Indirect comparison of randomised controlled trials: comparative efficacy of dexlansoprazole vs. esomeprazole in the treatment of gastro-oesophageal reflux disease.
Tan, SC; Wu, MS; Xiong, T, 2013
)
2.06
"Dexlansoprazole is a new PPI and lacks of evidence in support of a role in H."( High Efficacy of Levofloxacin-Dexlansoprazole-Based Quadruple Therapy as a First Line Treatment for Helicobacter pylori Eradication in Thailand.
Mahachai, V; Prapitpaiboon, H; Vilaichone, RK, 2015
)
1.43
"Dexlansoprazole MR is a novel Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole, designed to prolong the plasma concentration-time profile of dexlansoprazole and extend duration of acid suppression with once-daily (QD) dosing."( Pharmacokinetics and pharmacodynamics of a known active PPI with a novel Dual Delayed Release technology, dexlansoprazole MR: a combined analysis of randomized controlled clinical trials.
Atkinson, SN; Mulford, D; Vakily, M; Wu, J; Zhang, W, 2009
)
2.01
"Dexlansoprazole MR is a proton pump inhibitor with a Dual Delayed Release (DDR) formulation designed to prolong the dexlansoprazole plasma concentration-time profile. "( Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility.
Atkinson, SN; Lee, RD; Mulford, D; Vakily, M; Wu, J, 2009
)
2.01
"Dexlansoprazole MR is a DDR formulation of dexlansoprazole, an enantiomer of lansoprazole, with two distinct drug release periods to prolong the plasma dexlansoprazole concentration-time profile and extend duration of acid suppression."( Review article: dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy.
Dixit, T; Metz, DC; Mulford, D; Vakily, M, 2009
)
1.32
"Dexlansoprazole MR is a modified release formulation of a proton pump inhibitor being developed for the treatment of acid-related disorders. "( Effects of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor, on plasma gastrin levels in healthy subjects.
Atkinson, SN; Wu, J; Zhang, W, 2009
)
2.19
"Dexlansoprazole MR is a dual delayed release formulation of dexlansoprazole, an enantiomer of lansoprazole."( Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience.
Atkinson, SN; Dabholkar, AH; Metz, DC; Paris, MM; Peura, DA; Yu, P, 2009
)
2.13
"Dexlansoprazole MR is a Dual Delayed Release proton pump inhibitor formulated to extend the duration of acid suppression."( The effect of time-of-day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor.
Atkinson, SN; Lee, RD; Mulford, D; Wu, J, 2010
)
2.03
"Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole, designed to extend the duration of acid suppression."( The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease.
Atkinson, SN; Dabholkar, AH; Han, C; Paris, MM; Perez, MC; Peura, DA, 2011
)
2.1

Effects

Dexlansoprazole has a unique active formulation independent of time-of-day dosing or food. The drug releases drug at 2 points in time; the first peak occurs 1-2 hours after administration and the second occurs 4-5 hours after treatment.

ExcerptReferenceRelevance
"Dexlansoprazole has a unique active formulation independent of time-of-day dosing or food."( Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan.
Chaar, H; Rahal, MA; Rimmani, HH; Rustom, LBO; Sharara, AI; Shayto, RH, 2019
)
2.68
"Dexlansoprazole MR 30-90 mg has a safety profile comparable to that of lansoprazole."( Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience.
Atkinson, SN; Dabholkar, AH; Metz, DC; Paris, MM; Peura, DA; Yu, P, 2009
)
2.13
"Dexlansoprazole has a unique dual delayed-release formulation, which releases drug at 2 points in time; the first peak occurs 1-2 hours after administration and the second occurs within 4-5 hours after administration."( Dexlansoprazole in the treatment of esophagitis and gastroesophageal reflux disease.
Abel, C; Desilets, AR; Willett, K, 2010
)
2.52
"Dexlansoprazole MR has a unique dual delayed-release delivery system that was designed to address unmet needs that may accompany the use of single-release proton pump inhibitors (PPIs), specifically, their short plasma half-life and requirement for meal-associated dosing."( Dexlansoprazole MR for the management of gastroesophageal reflux disease.
Behm, BW; Peura, DA, 2011
)
2.53

Actions

ExcerptReferenceRelevance
"Dexlansoprazole tended to increase 24-h and nocturnal mean gastric pH among H."( Nocturnal acid breakthrough and esophageal acidification during treatment with dexlansoprazole as compared to omeprazole in patients with gastroesophageal reflux disease.
Blaachandran, A; Ghoshal, UC; Misra, A; Rai, S, 2022
)
1.67

Treatment

ExcerptReferenceRelevance
"Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn."( Dexlansoprazole for Heartburn Relief in Adolescents with Symptomatic, Nonerosive Gastro-esophageal Reflux Disease.
Gold, BD; Gremse, D; Hunt, B; Kierkuś, J; Perez, MC; Pilmer, B, 2017
)
2.62

Toxicity

Dexlansoprazole injection was safe and well tolerated for up to 5-day repeated intravenous administration dose of 30mg.

ExcerptReferenceRelevance
" Safety was assessed via adverse events, vital signs, electrocardiograms, clinical laboratory results and gastric biopsies."( Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience.
Atkinson, SN; Dabholkar, AH; Metz, DC; Paris, MM; Peura, DA; Yu, P, 2009
)
0.69
"The number of patients with > or =1 treatment-emergent adverse event per 100 patient-months was higher in placebo (24."( Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience.
Atkinson, SN; Dabholkar, AH; Metz, DC; Paris, MM; Peura, DA; Yu, P, 2009
)
0.69
" Safety was evaluated at months 1, 3, 6, 9 and 12/final visit through physical examinations, laboratory evaluations, endoscopies, gastric biopsies, fasting serum gastrin values and adverse events (AEs)."( The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease.
Atkinson, SN; Dabholkar, AH; Han, C; Paris, MM; Perez, MC; Peura, DA, 2011
)
0.66
" Safety assessments included monitoring of adverse events (AEs)."( Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD.
Kukulka, M; Perez, MC; Wu, J, 2012
)
0.66
"Dexlansoprazole injection was safe and well tolerated for up to 5-day repeated intravenous administration dose of 30 mg."( Safety, tolerability, pharmacokinetics and pharmacodynamics of dexlansoprazole injection in healthy Chinese subjects.
Jiao, HW; Li, YQ; Meng, L; Sun, LN; Wang, MF; Wang, YQ; Yan, ZY; Yu, L; Yu, LY; Yuan, ZQ; Zhang, HW, 2017
)
2.14
" Primary endpoints were treatment-emergent adverse events (TEAEs) in ≥ 5% of patients during treatment."( Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.
Gold, BD; Gremse, D; Hunt, B; Korczowski, B; Perez, MC; Pilmer, B, 2019
)
0.83
"Dexlansoprazole is safe and efficacious for healing EE and maintenance of healed EE in adolescents."( Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.
Gold, BD; Gremse, D; Hunt, B; Korczowski, B; Perez, MC; Pilmer, B, 2019
)
2.28

Pharmacokinetics

Dexlansoprazole MR, a proton pump inhibitor that uses Dual Delayed Release technology, produced a pharmacokinetic profile with a plasma concentration-time curve characterized by two distinct peaks. 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansuprazole.

ExcerptReferenceRelevance
"Pretransplantation, there were no significant differences in the pharmacokinetic parameters of (R)-lansoprazole between the 3 ABCBI C3435T genotypes."( Influence of ABCB1 C3435T polymorphism on the pharmacokinetics of lansoprazole and gastroesophageal symptoms in Japanese renal transplant recipients classified as CYP2C19 extensive metabolizers and treated with tacrolimus.
Habuchi, T; Inoue, K; Ishikawa, M; Kagaya, H; Kanno, S; Miura, M; Sagae, Y; Saito, M; Satoh, S; Suzuki, T; Tada, H, 2006
)
0.33
" No appreciable additional gain in the pharmacodynamic response was predicted for dexlansoprazole MR 120 mg."( Pharmacokinetics and pharmacodynamics of a known active PPI with a novel Dual Delayed Release technology, dexlansoprazole MR: a combined analysis of randomized controlled clinical trials.
Atkinson, SN; Mulford, D; Vakily, M; Wu, J; Zhang, W, 2009
)
0.79
"Dexlansoprazole MR, a proton pump inhibitor that uses Dual Delayed Release technology, produced a pharmacokinetic profile with a plasma concentration-time curve characterized by two distinct peaks and an extended duration of pharmacologically active dexlansoprazole concentration in plasma."( Pharmacokinetics and pharmacodynamics of a known active PPI with a novel Dual Delayed Release technology, dexlansoprazole MR: a combined analysis of randomized controlled clinical trials.
Atkinson, SN; Mulford, D; Vakily, M; Wu, J; Zhang, W, 2009
)
2.01
" The present study assesses the pharmacokinetic (PK) profile and safety of dexlansoprazole MR in adolescent patients."( Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD.
Kukulka, M; Perez, MC; Wu, J, 2012
)
0.9
" Cmax (691 and 1136  ng/mL) and area under the plasma concentration time curve (2886 and 5120  ng · h/mL) values for the 30- and 60-mg doses, respectively, were similar to results from previous phase 1 studies in healthy adults."( Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD.
Kukulka, M; Perez, MC; Wu, J, 2012
)
0.66
" Pharmacodynamic end-points were vasodilator-stimulated phosphoprotein P2Y(12) platelet reactivity index, maximal platelet aggregation to 5 and 20 μmol/l adenosine diphosphate, and VerifyNow P2Y12 platelet response units."( A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Bhatt, DL; Brooks, JK; Frelinger, AL; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2012
)
0.61
"Pharmacokinetic and pharmacodynamic responses with omeprazole demonstrated assay sensitivity."( A randomized, 2-period, crossover design study to assess the effects of dexlansoprazole, lansoprazole, esomeprazole, and omeprazole on the steady-state pharmacokinetics and pharmacodynamics of clopidogrel in healthy volunteers.
Bhatt, DL; Brooks, JK; Frelinger, AL; Lee, RD; Michelson, AD; Mulford, DJ; Nigam, A; Nudurupati, S; Wu, J, 2012
)
0.61
" All the subjects were sampled for pharmacokinetic (PK) analysis and 64 of them were monitored for 24-h intragastric pH prior to and after administration in the pharmacodynamic (PD) study."( Safety, tolerability, pharmacokinetics and pharmacodynamics of dexlansoprazole injection in healthy Chinese subjects.
Jiao, HW; Li, YQ; Meng, L; Sun, LN; Wang, MF; Wang, YQ; Yan, ZY; Yu, L; Yu, LY; Yuan, ZQ; Zhang, HW, 2017
)
0.69
" Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation."( Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study.
Bae, KS; Choi, HY; Choi, S; Han, S; Kim, B; Kim, S; Kim, YH; Lim, HS; Nam, JY; Song, GS, 2023
)
1.16
" Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole."( Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study.
Bae, KS; Choi, HY; Choi, S; Han, S; Kim, B; Kim, S; Kim, YH; Lim, HS; Nam, JY; Song, GS, 2023
)
1.35

Compound-Compound Interactions

The study found no effect of dexlansoprazole MR on the test substrate when administered with multiple once-daily doses.

ExcerptReferenceRelevance
"Most proton pump inhibitors are extensively metabolized by cytochrome P450 (CYP) isoenzymes, as are many other drugs, giving rise to potential drug-drug interactions."( Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayed-release formulation: results of four randomized, double-blind, crossover, placebo-controlled, single-centre studies.
Gunawardhana, L; Lee, RD; Mulford, D; Vakily, M; Wu, J, 2009
)
0.64
"Mean C(max) and AUC values were generally similar for each test substrate when administered with multiple once-daily doses of dexlansoprazole MR or placebo."( Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayed-release formulation: results of four randomized, double-blind, crossover, placebo-controlled, single-centre studies.
Gunawardhana, L; Lee, RD; Mulford, D; Vakily, M; Wu, J, 2009
)
0.85

Bioavailability

The results indicate that [14C]dexlansoprazole was well absorbed and extensively metabolized by oxidation, reduction and conjugation to 13 identified metabolites. The 90% CIs for the bioavailability of these test substrates were within the bioequivalency range of 0.

ExcerptReferenceRelevance
"Overall, the results indicate that [14C]dexlansoprazole was well absorbed and extensively metabolized by oxidation, reduction and conjugation to 13 identified metabolites."( Absorption, distribution, metabolism and excretion of [14C]dexlansoprazole in healthy male subjects.
Grabowski, B; Lee, RD, 2012
)
0.89

Dosage Studied

Dexlansoprazole MR dosed before 4 different meal times. Plasma concentration-time profile following administration of dexlansozole MR was characterized by two distinct peaks and a prolonged drug exposure.

ExcerptRelevanceReference
" The dexlansoprazole plasma concentration-time profile following administration of dexlansoprazole MR was characterized by two distinct peaks and a prolonged drug exposure during the 24-h dosing interval."( Pharmacokinetics and pharmacodynamics of a known active PPI with a novel Dual Delayed Release technology, dexlansoprazole MR: a combined analysis of randomized controlled clinical trials.
Atkinson, SN; Mulford, D; Vakily, M; Wu, J; Zhang, W, 2009
)
1.08
" The presence of food or time of dosing relative to food may affect dexlansoprazole absorption."( Clinical trial: the effect and timing of food on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR, a novel Dual Delayed Release formulation of a proton pump inhibitor--evidence for dosing flexibility.
Atkinson, SN; Lee, RD; Mulford, D; Vakily, M; Wu, J, 2009
)
0.81
"Non-standard dosing of currently marketed PPIs has produced incremental advances in acid control."( Review article: dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy.
Dixit, T; Metz, DC; Mulford, D; Vakily, M, 2009
)
0.6
" Twenty-four-hour electrocardiograms were obtained at baseline and during each dosing period."( Lack of electrocardiographic effect of dexlansoprazole MR, a novel modified-release formulation of the proton pump inhibitor dexlansoprazole, in healthy participants.
Atkinson, SN; Vakily, M; Wu, J, 2009
)
0.62
"To evaluate the pharmacokinetics and pharmacodynamics of dexlansoprazole MR dosed before 4 different meal times."( The effect of time-of-day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor.
Atkinson, SN; Lee, RD; Mulford, D; Wu, J, 2010
)
0.83
" There were no statistically significant differences in mean 24-h intragastric pH between dosing before dinner or an evening snack vs."( The effect of time-of-day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: evidence for dosing flexibility with a Dual Delayed Release proton pump inhibitor.
Atkinson, SN; Lee, RD; Mulford, D; Wu, J, 2010
)
0.59
" This extends plasma concentration and pharmacodynamic effects of dexlansoprazole MR beyond those of single-release PPIs and allows for dosing at any time of the day without regard to meals."( Dexlansoprazole MR for the management of gastroesophageal reflux disease.
Behm, BW; Peura, DA, 2011
)
2.05
" The recommended dosage for dexlansoprazole injection is 30 mg for an adequate gastric acid control."( Safety, tolerability, pharmacokinetics and pharmacodynamics of dexlansoprazole injection in healthy Chinese subjects.
Jiao, HW; Li, YQ; Meng, L; Sun, LN; Wang, MF; Wang, YQ; Yan, ZY; Yu, L; Yu, LY; Yuan, ZQ; Zhang, HW, 2017
)
0.99
" Dexlansoprazole has a unique active formulation independent of time-of-day dosing or food."( Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan.
Chaar, H; Rahal, MA; Rimmani, HH; Rustom, LBO; Sharara, AI; Shayto, RH, 2019
)
2.87
" For an "ideal PPI," achieving maximal absorption and sustaining pharmacodynamic effects through the 24-h dosing cycle are critical features."( Development of Dexlansoprazole Delayed-Release Capsules, a Dual Delayed-Release Proton Pump Inhibitor.
Grady, H; Kukulka, M; Mulford, D; Murakawa, Y, 2019
)
0.87
"Introduction: On the pharmaceutical market of Ukraine, there are six international non-proprietary names of proton pump inhibitors (PPIs) - Omeprazole, Pantoprazole, Lansoprazole, Rabeprazole, Esomeprazole, Dexlansoprazole, which differ in a number of pharmacokinetic and pharmacodynamic parameters, safety profile, range of dosage forms and their cost."( Qualimetric analysis of proton pump inhibitors in Ukraine.
Karimova, MM; Makarenko, OV; Masheiko, AM; Onul, NM, 2019
)
0.7
"All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group."( Comparison of Pharmacodynamics between Tegoprazan and Dexlansoprazole Regarding Nocturnal Acid Breakthrough: A Randomized Crossover Study.
Bae, KS; Choi, HY; Choi, S; Han, S; Kim, B; Kim, S; Kim, YH; Lim, HS; Nam, JY; Song, GS, 2023
)
1.35
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (2)

ClassDescription
sulfoxideAn organosulfur compound having the structure R2S=O or R2C=S=O (R =/= H).
benzimidazolesAn organic heterocyclic compound containing a benzene ring fused to an imidazole ring.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (8)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
WD repeat-containing protein 5Homo sapiens (human)IC50 (µMol)5.70000.22302.45625.9000AID1688549
Histone-lysine N-methyltransferase 2AHomo sapiens (human)IC50 (µMol)5.70000.45002.30935.9000AID1688549
NAD(+) hydrolase SARM1Homo sapiens (human)IC50 (µMol)3.40003.20004.90008.7000AID1622860; AID1622861
Cytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)IC50 (µMol)25.00004.47004.47004.4700AID1453445
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (89)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
negative regulation of transcription by RNA polymerase IIWD repeat-containing protein 5Homo sapiens (human)
skeletal system developmentWD repeat-containing protein 5Homo sapiens (human)
gluconeogenesisWD repeat-containing protein 5Homo sapiens (human)
regulation of DNA-templated transcriptionWD repeat-containing protein 5Homo sapiens (human)
regulation of transcription by RNA polymerase IIWD repeat-containing protein 5Homo sapiens (human)
positive regulation of gluconeogenesisWD repeat-containing protein 5Homo sapiens (human)
transcription initiation-coupled chromatin remodelingWD repeat-containing protein 5Homo sapiens (human)
positive regulation of DNA-templated transcriptionWD repeat-containing protein 5Homo sapiens (human)
regulation of embryonic developmentWD repeat-containing protein 5Homo sapiens (human)
regulation of cell divisionWD repeat-containing protein 5Homo sapiens (human)
regulation of cell cycleWD repeat-containing protein 5Homo sapiens (human)
regulation of tubulin deacetylationWD repeat-containing protein 5Homo sapiens (human)
apoptotic processHistone-lysine N-methyltransferase 2AHomo sapiens (human)
visual learningHistone-lysine N-methyltransferase 2AHomo sapiens (human)
post-embryonic developmentHistone-lysine N-methyltransferase 2AHomo sapiens (human)
anterior/posterior pattern specificationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
methylationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
circadian regulation of gene expressionHistone-lysine N-methyltransferase 2AHomo sapiens (human)
embryonic hemopoiesisHistone-lysine N-methyltransferase 2AHomo sapiens (human)
exploration behaviorHistone-lysine N-methyltransferase 2AHomo sapiens (human)
response to potassium ionHistone-lysine N-methyltransferase 2AHomo sapiens (human)
protein modification processHistone-lysine N-methyltransferase 2AHomo sapiens (human)
T-helper 2 cell differentiationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
transcription initiation-coupled chromatin remodelingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
positive regulation of DNA-templated transcriptionHistone-lysine N-methyltransferase 2AHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIHistone-lysine N-methyltransferase 2AHomo sapiens (human)
fibroblast proliferationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
negative regulation of fibroblast proliferationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
regulation of short-term neuronal synaptic plasticityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
spleen developmentHistone-lysine N-methyltransferase 2AHomo sapiens (human)
homeostasis of number of cells within a tissueHistone-lysine N-methyltransferase 2AHomo sapiens (human)
membrane depolarizationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
definitive hemopoiesisHistone-lysine N-methyltransferase 2AHomo sapiens (human)
protein-containing complex assemblyHistone-lysine N-methyltransferase 2AHomo sapiens (human)
cellular response to transforming growth factor beta stimulusHistone-lysine N-methyltransferase 2AHomo sapiens (human)
negative regulation of DNA methylation-dependent heterochromatin formationHistone-lysine N-methyltransferase 2AHomo sapiens (human)
signal transductionNAD(+) hydrolase SARM1Homo sapiens (human)
nervous system developmentNAD(+) hydrolase SARM1Homo sapiens (human)
response to glucoseNAD(+) hydrolase SARM1Homo sapiens (human)
NAD catabolic processNAD(+) hydrolase SARM1Homo sapiens (human)
cell differentiationNAD(+) hydrolase SARM1Homo sapiens (human)
negative regulation of MyD88-independent toll-like receptor signaling pathwayNAD(+) hydrolase SARM1Homo sapiens (human)
regulation of neuron apoptotic processNAD(+) hydrolase SARM1Homo sapiens (human)
innate immune responseNAD(+) hydrolase SARM1Homo sapiens (human)
response to axon injuryNAD(+) hydrolase SARM1Homo sapiens (human)
regulation of dendrite morphogenesisNAD(+) hydrolase SARM1Homo sapiens (human)
nervous system processNAD(+) hydrolase SARM1Homo sapiens (human)
protein localization to mitochondrionNAD(+) hydrolase SARM1Homo sapiens (human)
protein foldingCytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)
protein deglycosylationCytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (43)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
protein bindingWD repeat-containing protein 5Homo sapiens (human)
methylated histone bindingWD repeat-containing protein 5Homo sapiens (human)
histone H3K4 methyltransferase activityWD repeat-containing protein 5Homo sapiens (human)
histone bindingWD repeat-containing protein 5Homo sapiens (human)
minor groove of adenine-thymine-rich DNA bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
chromatin bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
protein bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
zinc ion bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
histone H3K4 methyltransferase activityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
identical protein bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
protein homodimerization activityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
unmethylated CpG bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
lysine-acetylated histone bindingHistone-lysine N-methyltransferase 2AHomo sapiens (human)
protein-cysteine methyltransferase activityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
histone H3K4 monomethyltransferase activityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
histone H3K4 trimethyltransferase activityHistone-lysine N-methyltransferase 2AHomo sapiens (human)
NAD+ nucleosidase activityNAD(+) hydrolase SARM1Homo sapiens (human)
protein bindingNAD(+) hydrolase SARM1Homo sapiens (human)
signaling adaptor activityNAD(+) hydrolase SARM1Homo sapiens (human)
NADP+ nucleosidase activityNAD(+) hydrolase SARM1Homo sapiens (human)
NAD+ nucleotidase, cyclic ADP-ribose generatingNAD(+) hydrolase SARM1Homo sapiens (human)
mannosyl-glycoprotein endo-beta-N-acetylglucosaminidase activityCytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)
hydrolase activity, hydrolyzing O-glycosyl compoundsCytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (37)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
nucleusWD repeat-containing protein 5Homo sapiens (human)
nucleoplasmWD repeat-containing protein 5Homo sapiens (human)
NSL complexWD repeat-containing protein 5Homo sapiens (human)
MLL1/2 complexWD repeat-containing protein 5Homo sapiens (human)
MLL3/4 complexWD repeat-containing protein 5Homo sapiens (human)
Set1C/COMPASS complexWD repeat-containing protein 5Homo sapiens (human)
MLL1 complexWD repeat-containing protein 5Homo sapiens (human)
mitotic spindleWD repeat-containing protein 5Homo sapiens (human)
ATAC complexWD repeat-containing protein 5Homo sapiens (human)
histone acetyltransferase complexWD repeat-containing protein 5Homo sapiens (human)
histone methyltransferase complexWD repeat-containing protein 5Homo sapiens (human)
nucleusHistone-lysine N-methyltransferase 2AHomo sapiens (human)
nucleoplasmHistone-lysine N-methyltransferase 2AHomo sapiens (human)
cytosolHistone-lysine N-methyltransferase 2AHomo sapiens (human)
MLL1 complexHistone-lysine N-methyltransferase 2AHomo sapiens (human)
histone methyltransferase complexHistone-lysine N-methyltransferase 2AHomo sapiens (human)
cytoplasmNAD(+) hydrolase SARM1Homo sapiens (human)
mitochondrionNAD(+) hydrolase SARM1Homo sapiens (human)
mitochondrial outer membraneNAD(+) hydrolase SARM1Homo sapiens (human)
cytosolNAD(+) hydrolase SARM1Homo sapiens (human)
microtubuleNAD(+) hydrolase SARM1Homo sapiens (human)
cell surfaceNAD(+) hydrolase SARM1Homo sapiens (human)
axonNAD(+) hydrolase SARM1Homo sapiens (human)
dendriteNAD(+) hydrolase SARM1Homo sapiens (human)
synapseNAD(+) hydrolase SARM1Homo sapiens (human)
protein-containing complexNAD(+) hydrolase SARM1Homo sapiens (human)
dendriteNAD(+) hydrolase SARM1Homo sapiens (human)
cytosolCytosolic endo-beta-N-acetylglucosaminidaseHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (13)

Assay IDTitleYearJournalArticle
AID1688549Inhibition of MLL1-WDR5 interaction in human MV4-11 cells assessed as reduction in MLL1 binding to WDR5 WIN site by 5-FAM probe based fluorescence polarization assay2020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
AID1688525Antiproliferative activity against human K562 cells harboring MLL12020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
AID1453445Inhibition of recombinant human C-MYC/DDK-tagged ENGase expressed in HEK293T cells using heat inactivated bovine ribonuclease B as substrate pretreated for 15 mins followed by substrate addition after 90 mins by SDS-PAGE analysis2017Bioorganic & medicinal chemistry letters, 07-01, Volume: 27, Issue:13
Repurposing of Proton Pump Inhibitors as first identified small molecule inhibitors of endo-β-N-acetylglucosaminidase (ENGase) for the treatment of NGLY1 deficiency, a rare genetic disease.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1688527Cytotoxicity against HUVEC cells2020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1688526Cytotoxicity against human L02 cells2020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1688524Antiproliferative activity against human MOLM-13 cells harboring MLL1-AF92020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
AID1688523Antiproliferative activity against human MV4-11 cells harboring MLL1-AF42020European journal of medicinal chemistry, Feb-15, Volume: 188Proton pump inhibitors selectively suppress MLL rearranged leukemia cells via disrupting MLL1-WDR5 protein-protein interaction.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (87)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's24 (27.59)29.6817
2010's49 (56.32)24.3611
2020's14 (16.09)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 97.59

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index97.59 (24.57)
Research Supply Index4.84 (2.92)
Research Growth Index4.70 (4.65)
Search Engine Demand Index174.74 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (97.59)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials38 (43.18%)5.53%
Reviews17 (19.32%)6.00%
Case Studies0 (0.00%)4.05%
Observational1 (1.14%)0.25%
Other32 (36.36%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (212)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase I, Open-Label Study to Assess the Pharmacokinetics and Relative Bioavailability of AZD4635 in Non-Smoking Healthy Male Subjects, With the Option to Assess Food Effect, pH Effect and Absolute Bioavailability [NCT03710434]Phase 121 participants (Actual)Interventional2018-11-01Completed
A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis. [NCT00321737]Phase 3445 participants (Actual)Interventional2006-05-31Completed
A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori [NCT01131026]Phase 360 participants (Anticipated)Interventional2010-06-30Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once- Daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis [NCT00251693]Phase 32,038 participants (Actual)Interventional2005-12-31Completed
A Randomized, Double-blind, Placebo-controlled Study of Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy [NCT01328652]Phase 480 participants (Anticipated)Interventional2011-06-30Not yet recruiting
Prospective, Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery [NCT04423588]Phase 40 participants (Actual)Interventional2022-01-01Withdrawn(stopped due to No participants enrolled.)
A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux [NCT01317472]11 participants (Actual)Interventional2011-03-31Terminated(stopped due to Principal investigator left institution)
Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Dexlansoprazole 60 mg Delayed Release Capsules and Esomeprazole 40 mg Delayed Release Capsules on Bone Homeostasis in Healthy Postmenopausal Female Subjects [NCT01216293]Phase 1247 participants (Actual)Interventional2011-01-31Completed
Oral Versus Intravenous Proton Pump Inhibitor Treatment in High-risk Bleeding Peptic Ulcers After Endoscopic Hemostasis: a Prospective Randomized Comparative Study [NCT01182597]Phase 3190 participants (Anticipated)Interventional2010-08-31Recruiting
Prevention of Recurrent Idiopathic Gastroduodenal Ulcer Bleeding: a Double-blind Randomized Trial [NCT01180179]Phase 4228 participants (Actual)Interventional2010-06-30Completed
A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda G [NCT03131895]Phase 1116 participants (Actual)Interventional2017-04-25Completed
Effectiveness of Physiologic Testing in PPI Non-Responders [NCT03202537]Early Phase 1240 participants (Actual)Interventional2017-07-01Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansopraz [NCT02873702]Phase 337 participants (Actual)Interventional2016-12-21Terminated(stopped due to Compound is not expected to change the current treatment practice or fill significant clinical need for patients in China over currently available EE agents.)
Comparison of Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH by the Prior Administration of a Proton-pum [NCT02251184]Phase 431 participants (Actual)Interventional2000-10-31Completed
A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20mg Compared to Lansoprazole 30mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Gastric Ulcer Subjects With or Without Helicoba [NCT03050307]Phase 3234 participants (Actual)Interventional2017-04-17Completed
An Open-label Therapeutic Efficacy Study of Tirosint (Levothyroxine Sodium) Capsules in Thyroidectomized Patients Taking Proton Pump Inhibitors [NCT03094416]Phase 466 participants (Actual)Interventional2018-07-30Completed
An Open-label, Randomized, 4-treatment, 3-period, Crossover Interaction Study, Evaluating the Effect of Esomeprazole 40 mg, Omeprazole 80 mg or Lansoprazole 60 mg on the Pharmacodynamics and the Pharmacokinetics of Clopidogrel in Healthy Volunteers [NCT01147588]Phase 1149 participants (Actual)Interventional2010-05-31Completed
Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction. A Prospective, Mono-center, Placebo- and Active Treatment-controlled, Randomized, Cross Over Study. [NCT01175200]82 participants (Actual)Interventional2010-09-30Completed
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery [NCT03859102]80 participants (Anticipated)Interventional2018-12-17Recruiting
Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial [NCT03829150]202 participants (Actual)Interventional2017-03-01Completed
A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis [NCT00255164]Phase 3451 participants (Actual)Interventional2006-01-31Completed
A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer [NCT03794596]Phase 20 participants (Actual)Interventional2019-09-30Withdrawn(stopped due to IP breach)
A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg [NCT04167670]Phase 31,046 participants (Actual)Interventional2019-12-10Completed
A Phase 3, Randomized, Double-Blind, Two Phase, Multicenter Study to Evaluate the Efficacy and Safety of Vonoprazan 20 mg Compared to Lansoprazole 30 mg for Healing in Patients With Erosive Esophagitis and to Evaluate the Efficacy and Safety of Vonoprazan [NCT04124926]Phase 31,027 participants (Actual)Interventional2019-10-28Completed
A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients [NCT05933031]Phase 2381 participants (Anticipated)Interventional2023-02-27Recruiting
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients [NCT03498456]Phase 3284 participants (Actual)Interventional2018-06-28Completed
Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study [NCT03130452]Phase 4280 participants (Anticipated)Interventional2017-02-01Active, not recruiting
A Phase 1, Randomized, Open-Label, Parallel-Design, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Capsules in Infants Aged 1 to 11 Months With Acid-Related Diseases [NCT02442752]Phase 10 participants (Actual)Interventional2025-06-15Withdrawn(stopped due to Withdrawn: Business decision (no enrollment))
A Phase 1, Open-label, Randomized, Crossover Study to Assess the Drug-drug Interaction of Acid Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of Lumicitabine (JNJ-64041575) in Healthy Adult Subjects [NCT03468777]Phase 118 participants (Actual)Interventional2018-03-06Terminated(stopped due to The study has been terminated due to pending data analysis)
A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Dexlansoprazole (30 mg QD) Compared to Placebo on Heartburn Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD) [NCT02873689]Phase 3217 participants (Actual)Interventional2016-12-27Completed
A Randomized Double-Blind, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helic [NCT03050359]Phase 3533 participants (Actual)Interventional2017-04-05Completed
A Randomized, Open Label, Parallel, Single and Multiple Doses Designed Clinical Study to Evaluate Comparative Pharmacokinetics (PK)-Pharmacodynamics (PD) After Oral Administration of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Health [NCT03488186]Phase 124 participants (Actual)Interventional2018-07-19Completed
A Randomized, Open-label, Multiple Dose, Two-part Phase I Clinical Trial to Compare the Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of DWP14012 After Administrations of DWP14012 Alone and Combinations of DWP14012, Clarithromycin and Amoxici [NCT03487562]Phase 148 participants (Actual)Interventional2018-04-08Completed
A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjec [NCT04877834]Phase 160 participants (Actual)Interventional2021-09-18Completed
A Phase 1, Randomized, Open-Label, Single-Center, Single-Dose, Two-Period, Two-Part Crossover Study in Healthy Subjects to Compare the Bioavailability of Dexlansoprazole From Dexlansoprazole Delayed-Release Capsules 30 mg and 60 mg Manufactured by Takeda [NCT03801148]Phase 1122 participants (Actual)Interventional2019-01-10Completed
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux [NCT01328392]0 participants (Actual)Interventional2011-05-31Withdrawn(stopped due to The sponsor did not fund the study.)
Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg DR Capsules (Takeda Pharmaceuticals America Inc., USA) [NCT02529787]Phase 160 participants (Actual)Interventional2013-02-28Completed
Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples [NCT01216267]200 participants (Actual)Interventional2010-06-30Completed
Oral vs Intravenous Proton Pump Inhibitor(PPI) in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial [NCT01123031]Phase 40 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to The study was terminated and the PI has left the institution.)
Can Detection of Fragments of Cleaved E-cadherin in Tissue and/or Blood be of Value for Identifying and Monitoring Patients With PPI-responsive Heartburn? [NCT01149395]Phase 140 participants (Actual)Interventional2010-06-30Completed
Intraluminal Therapy for Helicobacter Pylori Infection [NCT03124420]Phase 4100 participants (Actual)Interventional2017-04-28Completed
A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole [NCT02892409]Phase 130 participants (Actual)Interventional2016-09-05Completed
A Phase 1, Randomized, Open-Label, Parallel Design, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Delayed Release Capsules in Pediatric Subjects Ages 1 to 11 Years Old With Symptomatic Gastroesophageal Reflux Disease [NCT01045096]Phase 136 participants (Actual)Interventional2010-03-31Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg Once-Daily (QD) and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) [NCT00251745]Phase 3908 participants (Actual)Interventional2005-12-31Completed
A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome [NCT00663897]Phase 4329 participants (Actual)Interventional2008-05-31Completed
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of Fourteen Day Treatment With Lansoprazole 15 mg or 30 mg Once a Day in Frequent Nighttime Heartburn [NCT00701259]Phase 3852 participants (Actual)Interventional2007-01-31Completed
Novel Therapy Combining Regenerative Stimuli Immunomodulation to Preserve Beta Cell Function in New Onset Type 1 Diabetes [NCT00837759]Phase 27 participants (Actual)Interventional2009-02-28Terminated(stopped due to Changes to study personnel.)
A Phase 1 Clinical Trial to Evaluate Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety in Healthy Chinese Adults After Multiple Intravenous Administration of Dexlansoprazole [NCT03120273]Phase 170 participants (Anticipated)Interventional2017-05-05Recruiting
Helicobacter Eradication to Prevent Ulcer Bleeding in Aspirin Users: a Large Simple Randomised Controlled Trial [NCT01506986]Phase 430,024 participants (Actual)Interventional2012-03-31Completed
Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication [NCT02646332]248 participants (Actual)Interventional2015-12-31Completed
A Randomized, Double-Blind, Double-Dummy Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Compared to Lansoprazole 30 mg in the Treatment of Subjects With Erosive Esophagitis [NCT02388724]Phase 3481 participants (Actual)Interventional2015-03-24Completed
Distribution of Helicobacter Pylori According to the Use of Proton Pump Inhibitor [NCT02449941]30 participants (Actual)Observational2014-03-31Completed
A Phase I, Randomized, Double-blind, Placebo- and Positive-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of H008 (Carenoprazan Hydrochloride Tablets) in Healthy Volunteers [NCT05050188]Phase 124 participants (Actual)Interventional2021-06-24Completed
Prospective Study of the Effects of Helicobacter Pylori Eradication on Renal Functions and Proteinuria in Patients With Membranous Nephropathy [NCT00983034]70 participants (Actual)Interventional2006-03-31Completed
Role of Empiric Anti-reflux Therapy in Pediatric Otitis Media With Effusion - a Pilot Study [NCT01082029]Phase 465 participants (Actual)Interventional2010-03-31Completed
Randomized Controlled Trial to Evaluate the Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease [NCT01039558]30 participants (Anticipated)Interventional2009-12-31Completed
Comparison of Voice Therapy and Antireflex Therapy in the Treatment of Laryngopharyngeal Reflux-related Hoarseness: A Prospective Randomized Control Trial [NCT02530879]Phase 40 participants (Actual)Interventional2016-05-31Withdrawn(stopped due to Inability to recruit patients)
Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan [NCT03524833]Phase 420 participants (Actual)Interventional2018-05-07Completed
A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer [NCT02761512]Phase 3306 participants (Actual)Interventional2016-05-31Completed
Helicobacter Pylori Eradication Therapy on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection of Gastric Neoplastic Lesions: a Multicenter, Randomized, Double Blind, and Placebo Controlled Trial [NCT00926809]Phase 4232 participants (Anticipated)Interventional2008-09-30Recruiting
The Effect of High Dose Citric on PPI (Proton Pump Inhibitors)Induced False Negative H. Pylori UBT Rates [NCT00825630]Phase 4123 participants (Actual)Interventional2008-11-30Completed
Comparing Dexlansoprazole With Double-dose Lansoprazole to Achieve Sustained Symptomatic Response in Overweight and Obesity Patients With Reflux Esophagitis in Los Angeles Grades A & B [NCT02759393]Phase 4200 participants (Anticipated)Interventional2015-10-31Enrolling by invitation
A Study to Examine The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib When Administered Concomitantly To Healthy Subjects [NCT00952913]Phase 124 participants (Actual)Interventional2009-08-31Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease (GERD) [NCT00251758]Phase 3908 participants (Actual)Interventional2005-12-31Completed
A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (G [NCT00627016]Phase 3305 participants (Actual)Interventional2008-03-31Completed
A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric and Duodenal Ulcers During Long-term Treatment With Nonsteroid Anti-inflammatory Drug [NCT00787254]Phase 3366 participants (Actual)Interventional2007-04-30Completed
A Comparison of High-dose Dual Therapy and Half-dose Clarithromycin-containing Bismuth Quadruple Therapy for H.P Eradication in Elderly Patients [NCT04101708]Phase 4100 participants (Anticipated)Interventional2019-09-20Not yet recruiting
Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed. [NCT00644735]Phase 4750 participants (Anticipated)Interventional2002-12-31Completed
A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy [NCT00847808]Phase 3178 participants (Actual)Interventional2009-02-28Completed
Phase IV Study of Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial [NCT00708149]Phase 4120 participants (Actual)Interventional2009-06-30Completed
Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials [NCT05861687]Phase 2/Phase 351 participants (Actual)Interventional2021-08-01Completed
A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer [NCT04188119]Phase 242 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD [NCT00624546]24 participants (Actual)Observational2009-01-31Terminated(stopped due to Expected recruitment numbers have not been achieved.)
A Phase III, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial of 14 Day Treatment With Lansoprazole 15 mg Once a Day in Frequent Heartburn [NCT00390390]Phase 3576 participants Interventional2006-06-30Completed
The Occurrence of Peptic Ulcer Disease and Its Complications in Ischemic Heart Patients Taking Aspirin and Clopidogrel With or Without Co-prescription of Proton Pump Inhibitor [NCT00854776]300 participants (Anticipated)Interventional2009-01-31Recruiting
Therapeutic Response to Lansoprazole Among Different Subgroups of Functional Dyspepsia: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial [NCT01040455]Phase 430 participants (Actual)Interventional2009-12-31Terminated(stopped due to failure to recruit enough patients)
Effect of Rabeprazole and Lansoprazole on Reflux Esophagitis in Relation to CYP2C19 Genotype Status: A Prospective, Randomized, Multicenter Study [NCT01008696]Phase 4217 participants (Actual)Interventional2007-05-31Completed
Combination Therapy With Sitagliptin (DPP 4 Inhibitor) and Lansoprazole (PPI) Inhibitor) to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes [NCT01155284]Phase 270 participants (Actual)Interventional2010-08-31Completed
A Randomized, Placebo-Controlled Assessment of Lansoprazole 30 mg Bid in the Treatment of Gastroesophageal Reflux Associated With Laryngitis [NCT00369265]Phase 418 participants (Actual)Interventional2006-08-31Terminated(stopped due to Pharmaceutical company purchased by another company and funding was terminated.)
A Phase 1, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole Modified Release Capsules (30 mg and 60 mg) in Adolescents With Symptomatic Gastroesophageal Reflux Disease [NCT00847210]Phase 136 participants (Actual)Interventional2009-05-31Completed
Evaluation and Treatment of Reflux Disease in Patients With Head and Neck Cancer Undergoing Radiation Therapy That Causes Significant Mucositis in the Reflux Field and Xerostomia [NCT00928161]0 participants (Actual)Interventional2012-11-30Withdrawn
Vonoprazan Study In Patients With Erosive Esophagitis to Evaluate Long-term Safety: A Study to Evaluate the Safety of Long-term Administration of Vonoprazan in Maintenance Treatment in Patients With Erosive Esophagitis (EE) [NCT02679508]Phase 4208 participants (Actual)Interventional2016-03-20Completed
A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori [NCT01061437]Phase 31,859 participants (Actual)Interventional2009-06-30Completed
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma [NCT03015610]Phase 341 participants (Actual)Interventional2017-10-31Active, not recruiting
A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric And Duodenal Ulcers During Long-Term Treatment With Low Dose Aspirin. [NCT00762359]Phase 3461 participants (Actual)Interventional2007-05-31Terminated(stopped due to AG-1749 superior to Gefarnate in ulcer prevention)
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion [NCT00546117]16 participants (Actual)Interventional2007-10-31Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-390MR (60 mg Once-daily [QD] and 90 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis [NCT00251719]Phase 32,054 participants (Actual)Interventional2005-12-31Completed
A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taki [NCT00175032]Phase 31,045 participants (Actual)Interventional2003-07-31Completed
Pharmacogenomics-Based Tailor-Made Strategy for Eradication of Helicobacter Pylori [NCT00149084]Phase 3296 participants Interventional2003-04-30Recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis [NCT00255151]Phase 3451 participants (Actual)Interventional2006-01-31Completed
A Phase 3, Open-Label Study to Assess the Long-Term Safety of Dexlansoprazole MR (60 mg QD and 90 mg QD) [NCT00255190]Phase 3591 participants (Actual)Interventional2006-01-31Completed
A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole MR (30 mg QD and 60 mg QD) Compared to Placebo on Symptom Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD) [NCT00321984]Phase 3947 participants (Actual)Interventional2006-06-30Completed
The Relationship Between Gastroesophageal Reflux and Pediatric Rhinitis: Significance of Pale/Blue Colored Turbinate. A Randomized Controlled Trial [NCT02278081]Phase 498 participants (Anticipated)Interventional2015-01-31Not yet recruiting
Lansoprazole in Preterm Infants With Gastroesophageal Reflux [NCT01946971]Phase 1/Phase 212 participants (Actual)Interventional2013-09-30Completed
"A Screen and Treat Helicobacter Pylori Eradication Trial in 14-18 Years Old Adolescents Residing in Three Regions of Chile: Effectiveness and Microbiological-host Implications" [NCT05926804]500 participants (Anticipated)Interventional2022-08-02Recruiting
Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers [NCT00573924]66 participants (Actual)Interventional2006-02-28Completed
A Multicenter, Randomized, Double-blind, Double-simulation, Active Comparator-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules at Different Dosages in Patients With Reflux Esophagitis [NCT04531475]Phase 290 participants (Anticipated)Interventional2019-01-22Recruiting
Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial [NCT01607918]Phase 41,300 participants (Anticipated)Interventional2012-02-29Recruiting
A Phase 2, Double-Blind, 12-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules in Pediatric Subjects Aged 2 to 11 Years With Symptomatic Nonerosive Gastroesophageal Reflu [NCT02616302]Phase 270 participants (Anticipated)Interventional2023-02-20Recruiting
Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection [NCT02541786]Phase 4177 participants (Actual)Interventional2015-01-31Completed
Helicobacter Pylori Eradication With Berberine Hydrochloride, Lansoprazole, Amoxicillin and Bismuth Versus Clarithromycin Bismuth, Lansoprazole and Amoxicillin: A Randomized, Open-label, Non-inferiority, Phase Ⅳ Trial [NCT02633930]Phase 4566 participants (Actual)Interventional2015-12-31Completed
Fourteen-Day Vonoprazan-Based Dual Therapy With Amoxicillin as First-Line Helicobacter Pylori Treatment in Comparison With Extended Sequential Therapy: A Randomized Controlled Trial in Taiwan [NCT06156085]Phase 4318 participants (Anticipated)Interventional2023-11-14Recruiting
A Multicenter, Randomized, Double-blinded, Placebo-controlled Pilot Study to Evaluate the Efficacy and Safety of Rebamipide as an Adjuvant Regimen to Heal erosIve Reflux Esophagitis (REPAIR) [NCT02755753]Phase 4143 participants (Actual)Interventional2014-01-31Completed
A Multi-centred, Phase IV, Post-Marketing, Prospective, Randomized, Double-Blind Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease W [NCT00637845]Phase 4248 participants (Actual)Interventional2002-06-30Completed
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe [NCT00641602]Phase 41,000 participants (Anticipated)Interventional2002-12-31Completed
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial [NCT01093755]Phase 430 participants (Actual)Interventional2010-03-31Completed
[NCT00625274]Phase 4100 participants (Anticipated)Interventional2004-06-30Completed
Response to Oral Lansoprazole of Inorganic Pyrophosphate Levels in Patients With Grönblad-Stranberg Disease (Pseudoxanthoma Elasticum) [NCT04660461]Phase 420 participants (Anticipated)Interventional2020-02-04Recruiting
A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD [NCT00410592]Phase 490 participants (Anticipated)Interventional2006-10-31Completed
A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis. [NCT00471094]Phase 2831 participants (Actual)Interventional2007-05-31Completed
Proton Pump Inhibitor Therapy for Mild to Moderate Obstructive Sleep Apnea [NCT00211614]0 participants (Actual)Interventional2006-07-31Withdrawn(stopped due to No enrollment.)
A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease. [NCT00220818]Phase 124 participants (Actual)Interventional2005-01-31Completed
[NCT01481844]Phase 3101 participants (Actual)Interventional2011-11-30Completed
Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura [NCT00467571]Phase 426 participants (Actual)Interventional2006-03-31Completed
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs [NCT04840550]Phase 3390 participants (Anticipated)Interventional2021-05-07Recruiting
A Randomized, Open-label, 2x2 Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of AD-212-A or AD-2121 in Healthy Adult Volunteers [NCT06025773]Phase 124 participants (Anticipated)Interventional2023-09-08Not yet recruiting
A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions [NCT01046253]Phase 150 participants (Actual)Interventional2004-01-31Completed
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan [NCT03079050]Phase 433 participants (Actual)Interventional2017-02-27Completed
Open Label, Randomized, Two-treatment, Three-period, Three-sequence, Partial Replicate Oral Bioequivalence Study of Lansoprazole 30 mg DR Capsules of Dr.Reddy's Laboratories Limited, India Comparing With That of PREVACID® (Containing Lansoprazole) 30 mg D [NCT01270308]Phase 148 participants (Actual)Interventional2008-12-31Completed
Predictors of PPI Response in Eosinophilic Esophagitis [NCT01479231]Phase 1/Phase 20 participants (Actual)Interventional2012-03-31Withdrawn(stopped due to Souces of funding have been terminated)
[NCT00299845]Phase 40 participants (Actual)InterventionalWithdrawn
A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects [NCT02615184]Phase 276 participants (Anticipated)Interventional2023-05-23Recruiting
An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients [NCT00352261]Phase 480 participants Interventional2006-01-31Completed
Lansoprazole Disposition in Young Children With Cystic Fibrosis [NCT00458614]Phase 118 participants Interventional2006-06-30Completed
The Effect of Proton Pump Inhibition on Palpitations With no Apparent Cause. A Double Blinded Randomized Placebo Controlled Trial [NCT03273634]Phase 4150 participants (Actual)Interventional2017-05-20Completed
Safety and Efficacy of Lansoprazole in Patients With Reflux Disease. An Open, Single Arm, Long-term Study [NCT01135368]Phase 4506 participants (Actual)Interventional2002-06-30Completed
The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain [NCT00472186]Phase 42 participants (Actual)Interventional2008-06-30Terminated(stopped due to Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed)
A Phase 1, Randomized, Open-Label, 2-Period, Crossover Design Study to Assess the Effects of Multiple Oral Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healt [NCT00942175]Phase 1160 participants (Actual)Interventional2009-12-31Completed
Randomized Comparison of PPI Versus no PPI on Top of Standard Dose Clopidogrel Therapy in Patients Stratified Based on CYC2C19 Activity Via a Genetic Point of Care System. [NCT01512953]Phase 4522 participants (Anticipated)Interventional2011-01-31Recruiting
Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial [NCT01537055]Phase 4600 participants (Anticipated)Interventional2012-02-29Recruiting
A Prospective, Randomized, Double-Blind Protocol to Compare the Efficacy of Lansoprazole to Ranitidine in Healing Pre-Existing and/or Preventing the Development of Gastroduodenal Stress Ulceration and Postoperative Bleeding in Patients Undergoing Elective [NCT00220909]Phase 440 participants (Anticipated)Interventional2005-09-30Terminated(stopped due to Recruitment slow)
Phase 4 Study, Assessing the Efficacy of Lansoprazole and Domperidone Combination on Intragastric and Intraesophageal Acidity [NCT02958046]Phase 412 participants (Actual)Interventional2014-01-31Completed
A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates With Clinically-Evident Gastroesophageal Reflux Disease. [NCT00174928]Phase 124 participants (Actual)Interventional2005-05-31Completed
A Phase 2, Open-Label Multicenter Study to Evaluate the Pharmacodynamics of Intravenous Lansoprazole to That of Oral Lansoprazole in Subjects With Erosive Esophagitis [NCT00175045]Phase 268 participants (Actual)Interventional2003-06-30Completed
Phase III: The Study of Acid Reflux in Children With Asthma [NCT00442013]Phase 4306 participants (Actual)Interventional2007-03-31Completed
A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis [NCT04022096]Phase 3351 participants (Actual)Interventional2019-06-18Completed
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED [NCT00685295]Phase 1/Phase 260 participants (Actual)Interventional2008-08-31Completed
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial [NCT00638456]Phase 232 participants (Actual)Interventional2008-02-29Completed
Cardiac Safety Evaluation of Lansoprazole/Domperidone 30/30 mg Sustained Release Capsule Formulation [NCT03355170]Phase 40 participants (Actual)Interventional2018-03-01Withdrawn(stopped due to The sponsor decided to continue with a different design and a different protocol.)
A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy ( Lansoprazole; Solutab) in the Management of Childhood Asthma [NCT00237068]Phase 4100 participants (Anticipated)Interventional2006-03-31Active, not recruiting
Phase 1, Open-label, Partially Randomized, Parallel-group Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Single-dose Simeprevir (SMV), Odalasvir (ODV), and AL-335 Administered as a Fixed-dose Combination (FDC) Compared With the [NCT03059303]Phase 172 participants (Actual)Interventional2017-02-20Terminated(stopped due to Decision to discontinue development of investigational Hep C treatment regimen JNJ-4178: 3 direct acting antivirals - AL-335, ODV & SMV.)
A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole [NCT01505127]Phase 3650 participants (Actual)Interventional2012-01-31Completed
A Phase Ⅲ Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Ilaprazole (20mg QD) in Adult Patients With Erosive Esophagitis [NCT01509261]Phase 3292 participants (Actual)Interventional2010-07-31Completed
The Effect of Dexilant Treatment on Esophageal Hypersensitivity in GERD Related Non Cardiac Chest Pain Patients [NCT01637571]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Sponsor could not fund)
Levofloxacin-containing Therapy for Helicobacter Pylori Treatment [NCT01667718]Phase 4161 participants (Actual)Interventional2012-05-31Completed
[NCT02490449]356 participants (Anticipated)Interventional2014-12-31Enrolling by invitation
A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate the Safety and Efficacy in Diminishing Insulin Requirements Utilizing Oral Cyclosporine With Oral Lansoprazole in Children and Adults With Existing Type 1 Diabetes Me [NCT01762657]Phase 30 participants (Actual)Interventional2014-09-30Withdrawn(stopped due to Study stopped prior to Patient Enrollment)
A Pilot Study - Lansoprazole in Preterm Infants With Gastroesophageal Reflux [NCT01778101]Phase 25 participants (Actual)Interventional2013-01-31Completed
The Effect of Propolis and Nutritional Education in Patients With H. Pylori on Gastrointestinal Symptoms [NCT05259007]Phase 496 participants (Anticipated)Interventional2022-02-22Not yet recruiting
Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males [NCT01820104]Phase 116 participants (Actual)Interventional2013-03-31Completed
The Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole: a Randomised Placebo-controlled Multi-centre Clinical Trial [NCT04965298]Phase 3298 participants (Anticipated)Interventional2021-06-16Recruiting
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (20 mg Once-Daily) Compared to AG-1749 (30mg Once-Daily) in Patients With Erosive Esophagitis [NCT01452698]Phase 3409 participants (Actual)InterventionalCompleted
A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole [NCT03011125]Phase 128 participants (Anticipated)Interventional2017-01-31Completed
A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vonoprazan (20 mg) and Lansoprazole (30 mg) in Healthy Subjects [NCT04729101]Phase 144 participants (Actual)Interventional2021-01-28Completed
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Lo [NCT01452763]Phase 3621 participants (Actual)Interventional2011-10-31Completed
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long- [NCT01456247]Phase 3439 participants (Actual)Interventional2012-03-31Completed
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg Once-Daily) Compared to AG-1749 (15 mg Once-Daily) in a 24-week Maintenance Treatment in Patients With Healed Erosive Esophagitis (EE). [NCT01459367]Phase 3607 participants (Actual)Interventional2011-10-31Completed
Effect of Histamine 2 Receptor Antagonist (H2RA) and Proton Pump Inhibitor (PPI) on the Positivity Rates and Clinical Outcomes of Coronavirus Disease-19 (COVID-19). [NCT04834752]400,000 participants (Anticipated)Observational2021-05-01Not yet recruiting
A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer [NCT04784910]Phase 3416 participants (Anticipated)Interventional2021-03-31Not yet recruiting
Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors [NCT00204373]Phase 472 participants (Actual)Interventional2003-03-31Completed
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease [NCT00215787]20 participants (Actual)Interventional2005-09-30Completed
The Possible Efficacy and Safety of Lansoprazole Co-administration With Neoadjuvant Chemotherapy in Women With Breast Cancer [NCT04874935]Phase 366 participants (Actual)Interventional2021-06-10Completed
A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric pH Modification on the Pharmacokinetics of MLN1117 in Healthy Subjects [NCT02625259]Phase 154 participants (Actual)Interventional2016-01-08Completed
A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions. [NCT01045967]Phase 156 participants (Actual)Interventional2004-05-31Completed
A Randomized, Double-blind, Active Controlled Clinical Trial to Evaluate the Efficacy of Fexuprazan for the Prevention or Control of Gastritis Symptoms in Patients on Treatment With Systemic Steroids (FEAST) [NCT05946135]Phase 470 participants (Anticipated)Interventional2023-07-31Not yet recruiting
Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study [NCT04400136]Early Phase 145 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study [NCT03087162]Phase 4180 participants (Actual)Interventional2017-01-01Completed
The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness [NCT00637416]Phase 49 participants (Actual)Interventional2008-03-31Terminated(stopped due to Enrollment challenges)
A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Lo [NCT01452750]Phase 3642 participants (Actual)Interventional2011-10-31Completed
A Phase 3, Multicenter, Single-blind, AG-1749-controlled, Parallel-group, Long-term Extension Study to Evaluate the Safety and Efficacy of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long- [NCT01456260]Phase 3406 participants (Actual)Interventional2011-09-30Completed
A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B [NCT03128736]Phase 4175 participants (Actual)Interventional2014-04-01Completed
A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Study Assessing the Safety and Efficacy of Lansoprazole Microgranules Oral Suspension in Infants With Symptomatic Gastroesophageal Reflux [NCT00324974]Phase 3162 participants (Actual)Interventional2006-06-30Completed
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors [NCT01404832]Phase 4102 participants (Actual)Interventional2007-10-31Terminated(stopped due to Inadequate recruitment)
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease [NCT05267743]Phase 4218 participants (Actual)Interventional2021-02-16Completed
Takepron Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate] [NCT02151786]1,120 participants (Actual)Observational2007-01-31Completed
Takepron Capsules 15/ Orally Dispersing (OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin [NCT02099682]3,366 participants (Actual)Observational2010-08-31Completed
A Randomized, Double-Blind, Double-Dummy, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Oral Once-Daily Administration of TAK-438 10 or 20 mg Compared to Lansoprazole 15 mg in the Maintenance Treatment of Subjects With Endoscopic Hea [NCT02388737]Phase 3703 participants (Actual)Interventional2015-04-01Completed
A Phase 1, Randomized, Open-Label, Single Center, Multiple-Dose, Two-Period, Crossover Study to Assess the Bioavailability, Safety, and Pharmacodynamics of Two 30 mg Dexlansoprazole Delayed-Release Orally Disintegrating Tablets Administered on the Tongue [NCT02064907]Phase 152 participants (Actual)Interventional2014-02-28Completed
A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent Subjects Aged 12 to 17 Years With Symptomatic Non-Erosiv [NCT01642602]Phase 2104 participants (Actual)Interventional2012-07-31Completed
A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis [NCT04341428]Phase 3406 participants (Anticipated)Interventional2020-07-02Recruiting
A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer [NCT05448001]Phase 3328 participants (Anticipated)Interventional2022-08-15Not yet recruiting
A Multi-center, Randomized, Double-blind, Active-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of LXI-15028 Compared to Lansoprazole in the Treatment of Duodenal Ulcer in Chinese Patients for up to 6 Weeks [NCT05010954]Phase 3400 participants (Actual)Interventional2021-10-18Completed
A Phase 1, Single-Center, Open-Label, 2-Arm Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 mg and 60 mg Delayed-Release Capsules in Healthy Chinese Subjects [NCT03316976]Phase 140 participants (Actual)Interventional2017-11-22Completed
Randomized Placebo-Controlled Trial of BID Lansoprazole in Isolated Chronic Post Nasal Drip [NCT00335283]Phase 375 participants (Actual)Interventional2006-08-31Completed
The Evaluation of Effectiveness Between Empirical and Guided Therapy for Unexplained Non-Cardiac Chest Pain [NCT03319121]Phase 2/Phase 368 participants (Actual)Interventional2015-03-31Completed
Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing [NCT03043521]Phase 124 participants (Actual)Interventional2015-05-13Completed
A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial) [NCT03192059]Phase 243 participants (Actual)Interventional2017-07-01Completed
A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout [NCT02139046]Phase 31,790 participants (Actual)Interventional2014-04-30Completed
Multicentre, Prospective Study of First-line Antibiotic Therapy for Early-stage H. Pylori-Positive Gastric Pure (de Novo) Diffuse Large B-cell Lymphoma and Potential Predicting Factor for Treatment Outcome [NCT02388581]Phase 230 participants (Anticipated)Interventional2014-12-31Recruiting
A Relative Bioavailability Replicated Crossover Study of Lansoprazole 30 mg Delayed-Release Capsules Under Non-Fasting Conditions. [NCT01046084]Phase 150 participants (Actual)Interventional2003-08-31Completed
A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Duodenal Ulcer [NCT01452724]Phase 3372 participants (Actual)Interventional2011-10-31Completed
Do Proton Pump Inhibitors (PPIs) Increase Cardiovascular Risk? Effect of PPIs on Endothelial Function and ADMA. [NCT02022280]Phase 121 participants (Actual)Interventional2013-03-31Completed
An Open-Label Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Subjects : TAK-390MR(OD)_107 [NCT02096458]Phase 18 participants (Actual)Interventional2014-02-28Completed
The Efficacy and Safety of Proton Pump Inhibitor ( in Patients With Moderate Bleeding Risk and Coronary Artery Disease Undergoing Percutaneous Coronary: A Randomised, Open ,Compared With Control [NCT05820048]Phase 4300 participants (Anticipated)Interventional2023-05-01Not yet recruiting
Elucidation of Acid-Induced Pulmonary Inflammation [NCT00361972]Phase 2/Phase 317 participants (Actual)Interventional2006-08-31Terminated(stopped due to limited recruitment)
A Phase II Trial of Broad Spectrum Antibiotic Therapy for Early Stage, Non-progressive Chronic Lymphocytic Leukaemia Without Adverse Prognostic Factors [NCT01279252]Phase 271 participants (Anticipated)Interventional2011-07-31Completed
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Proof-of-Concept Trial to Assess Relief of Meal Induced Heartburn by a Combination of Lansoprazole 15 mg and Antacid Versus Lansoprazole 15 mg and Antacid (Calcium Carbonate and Magn [NCT01037452]Phase 2120 participants (Actual)Interventional2009-12-31Completed
A Phase 1, Open-label, Randomized, 2-Way Crossover Study to Assess the Effects of Acid-Reducing Agent(s) on the Pharmacokinetics of a Single Oral Dose of JNJ-64417184 in Healthy Adult Participants [NCT04453189]Phase 114 participants (Actual)Interventional2020-07-20Completed
A Phase 3, Randomized, Double Blind, Double-Dummy, Multicenter, Parallel Group Comparison Study to on Efficacy and Safety of Oral Once-Daily Administration of TAK-438 20 mg Comparing With AG-1749 in Patients With Gastric Ulcer. [NCT01452711]Phase 3482 participants (Actual)Interventional2011-11-30Completed
A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But [NCT05055128]Phase 2248 participants (Actual)Interventional2021-08-11Completed
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study [NCT04674774]217 participants (Actual)Interventional2021-03-04Active, not recruiting
An Open-Label, 2-Period, Fixed Sequence Study to Evaluate the Effect of Lansoprazole on the Pharmacokinetics of Neratinib in Healthy Subjects [NCT02334501]Phase 115 participants (Actual)Interventional2014-08-31Completed
Pharmacokinetic Study of Lansoprazole Capsules in Healthy Chinese Volunteer [NCT03488173]Phase 142 participants (Actual)Interventional2018-04-23Completed
Comparison of the Efficiency of Two Different PPI Formula in Treatment of Atypical GERD Patients, a Randomized Study [NCT03418337]120 participants (Anticipated)Interventional2017-08-01Recruiting
A Phase 2, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout and Moderate Renal Impairment [NCT02128490]Phase 2189 participants (Actual)Interventional2014-05-31Completed
Takepron Capsules 15/ Orally Dispersing(OD) Tablets 15 Special Drug Use Surveillance Long-term Use Survey on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs [NCT02099708]3,502 participants (Actual)Observational2010-10-31Completed
"Takepron Specified Drug-use Survey Gastroesophageal Reflux Disease With Dyspepsia Symptoms" [NCT01990339]14,965 participants (Actual)Observational2008-12-31Completed
A Randomized, Double-Blind, Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation [NCT02162758]Phase 26 participants (Actual)Interventional2014-07-31Terminated(stopped due to Business Decisions; No Safety Concerns)
A Phase 2 Multicenter, 36-Week Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn, [NCT01642615]Phase 263 participants (Actual)Interventional2012-07-31Completed
A Phase 4, Open-Label Study in Patients From Asia With Gastroesophageal Reflux Disease Treated With Dexlansoprazole [NCT02351960]Phase 4296 participants (Actual)Interventional2015-03-19Completed
A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects [NCT01681186]Phase 130 participants (Actual)Interventional2012-09-30Completed
Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions] [NCT02170207]63 participants (Actual)Observational2007-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00204373 (2) [back to overview]Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
NCT00204373 (2) [back to overview]The Median Survival From the Time of Diagnosis.
NCT00215787 (1) [back to overview]Presence of Reflux in Patients With Polyposis
NCT00251693 (6) [back to overview]Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
NCT00251693 (6) [back to overview]Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
NCT00251693 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
NCT00251693 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.
NCT00251693 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.
NCT00251693 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
NCT00251719 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
NCT00251719 (6) [back to overview]Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
NCT00251719 (6) [back to overview]Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
NCT00251719 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
NCT00251719 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
NCT00251719 (6) [back to overview]Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
NCT00251745 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00251745 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00251745 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00251745 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00251758 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00251758 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00251758 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00251758 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00255151 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00255151 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
NCT00255151 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
NCT00255151 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00255151 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00255151 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00255164 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00255164 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00255164 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00255164 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00255164 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
NCT00255164 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Hemoglobin Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Hematocrit Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Creatinine Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Calcium Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for White Blood Cell Count Values
NCT00255190 (30) [back to overview]Changes From Baseline to Final Visit in Fundus Biopsy Results
NCT00255190 (30) [back to overview]Changes From Baseline to Final Visit in Antrum Biopsy Results
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Total Bilirubin Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Systolic Blood Pressure
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Serum Gastrin Levels
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Pulse Rate
NCT00255190 (30) [back to overview]Mean Change From Baseline to Month 12 for Platelet Count Values
NCT00321737 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00321737 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00321737 (6) [back to overview]Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
NCT00321737 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
NCT00321737 (6) [back to overview]Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
NCT00321737 (6) [back to overview]Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
NCT00321984 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00321984 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00321984 (4) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
NCT00321984 (4) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
NCT00335283 (4) [back to overview]Sino Nasal Outcome Test (SNOT-20)
NCT00335283 (4) [back to overview]Rhinosinusitis Outcome Measure(RSOM-31)
NCT00335283 (4) [back to overview]Quality of Life Questionnaire (QOLRAD)
NCT00335283 (4) [back to overview]Post Nasal Drainage Symptom Response
NCT00361972 (2) [back to overview]Change in Lymphocyte Count
NCT00361972 (2) [back to overview]Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement
NCT00442013 (6) [back to overview]Airways Reactivity (Assessed by Methacholine PC20)
NCT00442013 (6) [back to overview]Rate of Episodes of Poor Asthma Control (EPAC)
NCT00442013 (6) [back to overview]Asthma Symptom Utility Index (ASUI)
NCT00442013 (6) [back to overview]Asthma-specific Quality of Life
NCT00442013 (6) [back to overview]Change in Juniper Asthma Control Score (ACS)
NCT00442013 (6) [back to overview]Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
NCT00546117 (5) [back to overview]Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar
NCT00546117 (5) [back to overview]Number of Participants With Normal Type A Tympanometry
NCT00546117 (5) [back to overview]Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire
NCT00546117 (5) [back to overview]Acoustic Reflectometry: Level of Risk as Defined by Manufacturer
NCT00546117 (5) [back to overview]Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear
NCT00627016 (3) [back to overview]Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
NCT00627016 (3) [back to overview]Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.
NCT00627016 (3) [back to overview]Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
NCT00638456 (3) [back to overview]Symptom Score
NCT00638456 (3) [back to overview]Upper Gastrointestinal Endoscopy Score
NCT00638456 (3) [back to overview]Number of Participants With Improvement of Espohageal Eosinophilia
NCT00685295 (3) [back to overview]Pain Reduction
NCT00685295 (3) [back to overview]Occurrence of Untoward Opioid Side Effects
NCT00685295 (3) [back to overview]Time to Analgesia
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Number of Participants With Adverse Events
NCT00762359 (46) [back to overview]Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
NCT00762359 (46) [back to overview]Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
NCT00762359 (46) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
NCT00762359 (46) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
NCT00787254 (48) [back to overview]Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
NCT00787254 (48) [back to overview]Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
NCT00787254 (48) [back to overview]Number of Participants With Adverse Events
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
NCT00787254 (48) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
NCT00787254 (48) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
NCT00787254 (48) [back to overview]Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
NCT00787254 (48) [back to overview]Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
NCT00825630 (1) [back to overview]Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.
NCT00837759 (6) [back to overview]Glycemia Control (Change in HbA1c Level)
NCT00837759 (6) [back to overview]Change in Anti-GAD Autoantibody Titers
NCT00837759 (6) [back to overview]Change in Anti-IA2 Titer
NCT00837759 (6) [back to overview]Change in C-peptide
NCT00837759 (6) [back to overview]Change in Insulin Dose
NCT00837759 (6) [back to overview]Change in ZnT8 Autoantibody Titer
NCT00847210 (8) [back to overview]Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.
NCT00847210 (8) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
NCT00847210 (8) [back to overview]Oral Clearance (CL/F) Pharmacokinetic Parameter.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.
NCT00847808 (14) [back to overview]Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.
NCT00847808 (14) [back to overview]Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.
NCT00942175 (5) [back to overview]Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).
NCT00942175 (5) [back to overview]Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.
NCT00942175 (5) [back to overview]Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.
NCT01008696 (3) [back to overview]Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19
NCT01008696 (3) [back to overview]Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire
NCT01008696 (3) [back to overview]Overall Assessment of Study Medication by Investigator
NCT01037452 (4) [back to overview]Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals
NCT01037452 (4) [back to overview]Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn
NCT01037452 (4) [back to overview]Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.
NCT01037452 (4) [back to overview]Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal
NCT01045096 (7) [back to overview]Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)
NCT01045096 (7) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))
NCT01045096 (7) [back to overview]Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))
NCT01045096 (7) [back to overview]Time to Reach the Peak Plasma Concentration (Tmax)
NCT01045096 (7) [back to overview]The Peak Plasma Concentration (Cmax)
NCT01045096 (7) [back to overview]Dose-normalized Peak Plasma Concentration (Cmax/Dose)
NCT01045096 (7) [back to overview]Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)
NCT01045967 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01045967 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01045967 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01046084 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01046084 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01046084 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01046253 (3) [back to overview]Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
NCT01046253 (3) [back to overview]AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01046253 (3) [back to overview]AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01093755 (2) [back to overview]Change in Inflammation Biomarker Tissue PGE2 Level
NCT01093755 (2) [back to overview]Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
NCT01135368 (36) [back to overview]Change From Baseline in Average Antrum Chronic Inflammation Score
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare
NCT01135368 (36) [back to overview]Change From Baseline in Corpus Chronic Inflammation Score
NCT01135368 (36) [back to overview]Change From Baseline in Enterochromaffin-like Cell Hyperplasia
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Adaptation With Glare
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Accommodation
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy
NCT01135368 (36) [back to overview]Change From Baseline in Antrum Atrophy
NCT01135368 (36) [back to overview]Change From Baseline in Antrum Intestinal Metaplasia
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Color Vision
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye
NCT01135368 (36) [back to overview]Ophthalmologic Examination - Visual Acuity
NCT01135368 (36) [back to overview]Change From Baseline in Corpus Intestinal Metaplasia
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptom - Heartburn
NCT01135368 (36) [back to overview]Change From Baseline in Blood Analysis - Follicle Stimulating Hormone
NCT01135368 (36) [back to overview]Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat
NCT01135368 (36) [back to overview]Change From Baseline in Blood Analysis - Luteinizing Hormone
NCT01135368 (36) [back to overview]Change From Baseline in Blood Analysis - Testosterone
NCT01135368 (36) [back to overview]Change From Baseline in Corpus Atrophy
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye
NCT01135368 (36) [back to overview]Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye
NCT01155284 (2) [back to overview]2 Hour C-peptide AUC in Response to MMTT
NCT01155284 (2) [back to overview]2 Hour C-peptide AUC in Response to MMTT
NCT01317472 (1) [back to overview]Change in Reflux Symptom Index (RSI)
NCT01404832 (2) [back to overview]Number of Participants With Eosinophilic Esophagitis
NCT01404832 (2) [back to overview]Number of Patients Who Had Resolution of Heartburn With Lansoprazole
NCT01642602 (2) [back to overview]The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment
NCT01642602 (2) [back to overview]Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period
NCT01642615 (6) [back to overview]Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period
NCT01642615 (6) [back to overview]Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period
NCT01642615 (6) [back to overview]Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8
NCT01642615 (6) [back to overview]Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24
NCT01642615 (6) [back to overview]Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24
NCT01642615 (6) [back to overview]Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment
NCT01681186 (9) [back to overview]Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
NCT01681186 (9) [back to overview]Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
NCT01681186 (9) [back to overview]Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)
NCT01681186 (9) [back to overview]Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
NCT01681186 (9) [back to overview]Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]
NCT01681186 (9) [back to overview]Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
NCT01681186 (9) [back to overview]Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)
NCT01681186 (9) [back to overview]Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation
NCT01681186 (9) [back to overview]Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]
NCT01990339 (2) [back to overview]Subjective Symptom Improvement Rate
NCT01990339 (2) [back to overview]Frequency of Adverse Events (Adverse Drug Reactions)
NCT02064907 (6) [back to overview]AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5
NCT02064907 (6) [back to overview]AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5
NCT02064907 (6) [back to overview]Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.
NCT02064907 (6) [back to overview]Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5
NCT02064907 (6) [back to overview]AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1
NCT02064907 (6) [back to overview]AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1
NCT02096458 (1) [back to overview]Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets
NCT02099682 (8) [back to overview]Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
NCT02099682 (8) [back to overview]Frequency of Adverse Drug Reactions
NCT02099682 (8) [back to overview]Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
NCT02099682 (8) [back to overview]Presence of Gastric or Duodenal Hemorrhagic Lesion
NCT02099682 (8) [back to overview]Treatment for Gastric/Duodenal Ulcer or Lesion
NCT02099682 (8) [back to overview]Presence or Absence of Endoscopic Examinations
NCT02099682 (8) [back to overview]Presence of Gastric or Duodenal Ulcer
NCT02099682 (8) [back to overview]Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
NCT02099708 (8) [back to overview]Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
NCT02099708 (8) [back to overview]Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion
NCT02099708 (8) [back to overview]Presence of Gastric or Duodenal Ulcer
NCT02099708 (8) [back to overview]Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion
NCT02099708 (8) [back to overview]Presence or Absence of Endoscopic Examinations
NCT02099708 (8) [back to overview]Treatment for Gastric/Duodenal Ulcer or Lesion
NCT02099708 (8) [back to overview]Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions
NCT02099708 (8) [back to overview]Frequency of Adverse Drug Reactions
NCT02128490 (3) [back to overview]Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
NCT02128490 (3) [back to overview]Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
NCT02128490 (3) [back to overview]Percentage of Participants With at Least One Gout Flare Requiring Treatment
NCT02139046 (3) [back to overview]Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
NCT02139046 (3) [back to overview]Percentage of Participants With at Least One Gout Flare Requiring Treatment
NCT02139046 (3) [back to overview]Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
NCT02151786 (8) [back to overview]Number of Participants Reporting One or More Adverse Drug Reactions
NCT02151786 (8) [back to overview]Number of Participants Reporting One or More Serious Adverse Drug Reactions
NCT02151786 (8) [back to overview]Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect
NCT02151786 (8) [back to overview]Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect
NCT02151786 (8) [back to overview]Percentage of Participants With Confirmed Hemostatic Effect
NCT02151786 (8) [back to overview]Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
NCT02151786 (8) [back to overview]Percentage of Participants With Observed Hemostatic Effect
NCT02151786 (8) [back to overview]Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
NCT02162758 (4) [back to overview]Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score
NCT02162758 (4) [back to overview]Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)
NCT02162758 (4) [back to overview]Percentage of Participants With Recurrence of IM With Dysplasia
NCT02162758 (4) [back to overview]Percentage of Participants With Erosive Esophagitis (EE)
NCT02170207 (5) [back to overview]Percentage of Participants With Observed Hemostatic Effect
NCT02170207 (5) [back to overview]Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment
NCT02170207 (5) [back to overview]Number of Participants Reporting One or More Adverse Drug Reactions
NCT02170207 (5) [back to overview]Percentage of Participants With Confirmed Hemostatic Effect
NCT02170207 (5) [back to overview]Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment
NCT02351960 (9) [back to overview]Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms
NCT02351960 (9) [back to overview]Percentage of 24-hour Acid Regurgitation-free Days
NCT02351960 (9) [back to overview]Percentage of 24-hour Heartburn-free Days
NCT02351960 (9) [back to overview]Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn
NCT02351960 (9) [back to overview]Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation
NCT02351960 (9) [back to overview]Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus
NCT02351960 (9) [back to overview]Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation
NCT02351960 (9) [back to overview]Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants
NCT02351960 (9) [back to overview]Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants
NCT02388724 (9) [back to overview]Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)
NCT02388724 (9) [back to overview]Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase
NCT02388724 (9) [back to overview]Number of Participants With Markedly Abnormal Vital Sign Measurements
NCT02388724 (9) [back to overview]Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings
NCT02388724 (9) [back to overview]Number of Participants With Markedly Abnormal Clinical Laboratory Findings
NCT02388724 (9) [back to overview]Change From Baseline in Serum Pepsinogen II
NCT02388724 (9) [back to overview]Change From Baseline in Serum Pepsinogen I
NCT02388724 (9) [back to overview]Change From Baseline in Serum Gastrin
NCT02388724 (9) [back to overview]Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment
NCT02388737 (9) [back to overview]Number of Participants With Abnormal Vital Sign Measurements
NCT02388737 (9) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02388737 (9) [back to overview]Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase
NCT02388737 (9) [back to overview]Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase
NCT02388737 (9) [back to overview]Change From Baseline in Serum Gastrin
NCT02388737 (9) [back to overview]Change From Baseline in Serum Pepsinogen I
NCT02388737 (9) [back to overview]Change From Baseline in Serum Pepsinogen II
NCT02388737 (9) [back to overview]Number of Participants With Abnormal Clinical Laboratory Findings
NCT02388737 (9) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCT02625259 (5) [back to overview]AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
NCT02625259 (5) [back to overview]AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
NCT02625259 (5) [back to overview]Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
NCT02625259 (5) [back to overview]Cmax: Maximum Observed Plasma Concentration for TAK-117
NCT02625259 (5) [back to overview]Part 1: Renal Clearance (CLr) of TAK-117
NCT02646332 (1) [back to overview]Number of Participants in Which H. Pylori Was Eradicated
NCT02679508 (24) [back to overview]Number of Participants With Fundic Gland Polyp
NCT02679508 (24) [back to overview]Number of Participants With G-cell Hyperplasia
NCT02679508 (24) [back to overview]Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body
NCT02679508 (24) [back to overview]Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase
NCT02679508 (24) [back to overview]Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body
NCT02679508 (24) [back to overview]Number of Participants With Hyperplastic Polyp
NCT02679508 (24) [back to overview]Number of Participants With Gastric Polyp
NCT02679508 (24) [back to overview]Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum
NCT02679508 (24) [back to overview]Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum
NCT02679508 (24) [back to overview]Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body
NCT02679508 (24) [back to overview]Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body
NCT02679508 (24) [back to overview]Number of Participants With Parietal Cell Protrusion/Hyperplasia
NCT02679508 (24) [back to overview]Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum
NCT02679508 (24) [back to overview]Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body
NCT02679508 (24) [back to overview]Number of Participants With Malignant Alteration of Epithelial Cells
NCT02679508 (24) [back to overview]Number of Participants With Atrophy in Greater Curvature of Antrum
NCT02679508 (24) [back to overview]Number of Participants With Multiple White and Flat Elevated Lesions
NCT02679508 (24) [back to overview]Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum
NCT02679508 (24) [back to overview]Percentage of Participants With Recurrence of Erosive Esophagitis (EE)
NCT02679508 (24) [back to overview]Percentage of Participants Who Healed EE at the End of Healing Phase
NCT02679508 (24) [back to overview]Number of Participants With Black Spots
NCT02679508 (24) [back to overview]Number of Participants With Cobblestone Mucosa
NCT02679508 (24) [back to overview]Number of Participants With Enterochromaffin-like-cell Hyperplasia
NCT02679508 (24) [back to overview]Number of Participants With Foveolar Hyperplasia
NCT02873689 (2) [back to overview]Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
NCT02873689 (2) [back to overview]Percentage of Days Without Nighttime Heartburn During Treatment
NCT02873702 (2) [back to overview]Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6
NCT02873702 (2) [back to overview]Healing Period: Percentage of Participants With Complete Healing of EE at Week 8
NCT02892409 (8) [back to overview]Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose
NCT02892409 (8) [back to overview]Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
NCT02892409 (8) [back to overview]Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose
NCT02892409 (8) [back to overview]Cmax: Maximum Observed Plasma Concentration for Bismuth
NCT02892409 (8) [back to overview]AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth
NCT02892409 (8) [back to overview]Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
NCT02892409 (8) [back to overview]Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth
NCT02892409 (8) [back to overview]Percentage of Participants Who Discontinue Due to an Adverse Event (AE)
NCT03050307 (4) [back to overview]Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
NCT03050307 (4) [back to overview]Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
NCT03050307 (4) [back to overview]Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
NCT03050307 (4) [back to overview]Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
NCT03050359 (4) [back to overview]Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4
NCT03050359 (4) [back to overview]Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
NCT03050359 (4) [back to overview]Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment
NCT03050359 (4) [back to overview]Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers
NCT03094416 (14) [back to overview]Sex Hormone Binding Globulin (SHBG)
NCT03094416 (14) [back to overview]Low Density Lipoprotein (LDL)-Cholesterol
NCT03094416 (14) [back to overview]High Density Lipoprotein (HDL)-Cholesterol
NCT03094416 (14) [back to overview]Free Triiodothyronine (FT3)
NCT03094416 (14) [back to overview]Free Thyroxine (FT4)
NCT03094416 (14) [back to overview]Very Low Density Lipoprotein (VLDL)-Cholesterol
NCT03094416 (14) [back to overview]Creatine Phosphokinase (CPK)
NCT03094416 (14) [back to overview]Thyroid Stimulating Hormone (TSH)
NCT03094416 (14) [back to overview]Angiotensin Converting Enzyme (ACE)
NCT03094416 (14) [back to overview]Cholesterol, Total
NCT03094416 (14) [back to overview]Triglycerides
NCT03094416 (14) [back to overview]Total Triiodothyronine (TT3)
NCT03094416 (14) [back to overview]Total Thyroxine (TT4)
NCT03094416 (14) [back to overview]Ferritin
NCT03131895 (3) [back to overview]AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
NCT03131895 (3) [back to overview]AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
NCT03131895 (3) [back to overview]Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
NCT03316976 (3) [back to overview]AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
NCT03316976 (3) [back to overview]AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole
NCT03316976 (3) [back to overview]Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
NCT03801148 (4) [back to overview]AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole
NCT03801148 (4) [back to overview]AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole
NCT03801148 (4) [back to overview]AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole
NCT03801148 (4) [back to overview]Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole
NCT04124926 (9) [back to overview]Maintenance Phase: Percentage of 24-hour Heartburn-free Days
NCT04124926 (9) [back to overview]Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24
NCT04124926 (9) [back to overview]Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24
NCT04124926 (9) [back to overview]Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3
NCT04124926 (9) [back to overview]Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8
NCT04124926 (9) [back to overview]Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2
NCT04124926 (9) [back to overview]Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8
NCT04124926 (9) [back to overview]Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2
NCT04124926 (9) [back to overview]Healing Phase: Percentage of 24-hour Heartburn-free Days
NCT04167670 (3) [back to overview]Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline
NCT04167670 (3) [back to overview]Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline
NCT04167670 (3) [back to overview]Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication
NCT04729101 (9) [back to overview]Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24)
NCT04729101 (9) [back to overview]Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss)
NCT04729101 (9) [back to overview]Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24)
NCT04729101 (9) [back to overview]Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration
NCT04729101 (9) [back to overview]Tmax at Steady State (Tmax,ss)
NCT04729101 (9) [back to overview]Time to Reach Cmax (Tmax)
NCT04729101 (9) [back to overview]Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)
NCT04729101 (9) [back to overview]Cmax at Steady State (Cmax,ss)
NCT04729101 (9) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT05055128 (6) [back to overview]Percentage of Heartburn-Free 24-hour Days
NCT05055128 (6) [back to overview]Number of Patients With Esophageal Mucosa Healing
NCT05055128 (6) [back to overview]Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score
NCT05055128 (6) [back to overview]Investigator Assessment of Symptoms by Frequency and Severity
NCT05055128 (6) [back to overview]Number of Patients With Adverse Events (AEs)
NCT05055128 (6) [back to overview]Percentage at Most-mild Heartburn 24-hour Days

Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.

number of participants with control of gastric acid production (NCT00204373)
Timeframe: up to 240 months from study enrollment

Interventionparticipants (Number)
Single Group72

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The Median Survival From the Time of Diagnosis.

The median survival from the time of diagnosis (NCT00204373)
Timeframe: survival or up to 240 months

Interventionyears (Median)
Single Group6.6

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Presence of Reflux in Patients With Polyposis

Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards. (NCT00215787)
Timeframe: one year

Interventionparticipants (Number)
Lansoprazole15

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Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of erosive esophagitis as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 8 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD79.7
Dexlansoprazole MR 90 mg QD74.1
Lansoprazole 30 mg QD65.0

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Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy for Change in LA Esophagitis Classification Grades C and D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 8 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD88.9
Dexlansoprazole MR 90 mg QD83.8
Lansoprazole 30 mg QD74.5

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Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 8 Weeks

InterventionPercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD85.3
Dexlansoprazole MR 90 mg QD85.8
Lansoprazole 30 mg QD79.0

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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 4 Weeks

InterventionPercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD66.2
Dexlansoprazole MR 90 mg QD68.8
Lansoprazole 30 mg QD64.8

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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 4 Weeks

InterventionPercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD77.0
Dexlansoprazole MR 90 mg QD78.8
Lansoprazole 30 mg QD76.5

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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

Percentage of subjects with complete healing of EE as assessed by endoscopy was analyzed for change in LA Esophagitis Classification grades A, B, C, or D to healed. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251693)
Timeframe: 8 weeks

InterventionPercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD92.3
Dexlansoprazole MR 90 mg QD92.2
Lansoprazole 30 mg QD86.1

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Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: 4 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD69.7
Dexlansoprazole MR 90 mg QD70.6
Lansoprazole 30 mg QD65.4

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Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: 8 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD87.6
Dexlansoprazole MR 90 mg QD93.3
Lansoprazole 30 mg QD87.7

[back to top]

Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: Week 8

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD77.8
Dexlansoprazole MR 90 mg QD86.3
Lansoprazole 30 mg QD78.9

[back to top]

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: 4 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD80.1
Dexlansoprazole MR 90 mg QD80.4
Lansoprazole 30 mg QD77.0

[back to top]

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: 8 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD86.9
Dexlansoprazole MR 90 mg QD89.4
Lansoprazole 30 mg QD84.6

[back to top]

Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method

Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed. (NCT00251719)
Timeframe: 8 Weeks

Interventionpercentage of subjects (Number)
Dexlansoprazole MR 60 mg QD93.1
Dexlansoprazole MR 90 mg QD94.9
Lansoprazole 30 mg QD91.5

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00251745)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD51.0
Dexlansoprazole MR 60 mg QD72.3
Dexlansoprazole MR 90 mg QD76.6

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00251745)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD49.6
Dexlansoprazole MR 60 mg QD62.0
Dexlansoprazole MR 90 mg QD64.4

[back to top]

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00251745)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD17.0
Dexlansoprazole MR 60 mg QD45.7
Dexlansoprazole MR 90 mg QD52.7

[back to top]

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00251745)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD24.9
Dexlansoprazole MR 60 mg QD44.8
Dexlansoprazole MR 90 mg QD49.1

[back to top]

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00251758)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD17.0
Dexlansoprazole MR 60 mg QD45.7
Dexlansoprazole MR 90 mg QD52.7

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00251758)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD49.6
Dexlansoprazole MR 60 mg QD62.0
Dexlansoprazole MR 90 mg QD64.4

[back to top]

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00251758)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD24.9
Dexlansoprazole MR 60 mg QD44.8
Dexlansoprazole MR 90 mg QD49.1

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00251758)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD51.0
Dexlansoprazole MR 60 mg QD72.3
Dexlansoprazole MR 90 mg QD76.6

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD48.3
Dexlansoprazole MR 60 mg QD87.1
Dexlansoprazole MR 90 mg QD85.4

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Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method

Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD25.7
Dexlansoprazole MR 60 mg QD86.6
Dexlansoprazole MR 90 mg QD82.1

[back to top]

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.

Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD14.3
Dexlansoprazole MR 60 mg QD66.4
Dexlansoprazole MR 90 mg QD64.5

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD29.5
Dexlansoprazole MR 60 mg QD79.7
Dexlansoprazole MR 90 mg QD79.2

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported. (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD19.2
Dexlansoprazole MR 60 mg QD95.8
Dexlansoprazole MR 90 mg QD94.4

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00255151)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD50.0
Dexlansoprazole MR 60 mg QD98.3
Dexlansoprazole MR 90 mg QD97.1

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD50.0
Dexlansoprazole MR 60 mg QD98.3
Dexlansoprazole MR 90 mg QD97.1

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD48.3
Dexlansoprazole MR 60 mg QD87.1
Dexlansoprazole MR 90 mg QD85.4

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported. (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD19.2
Dexlansoprazole MR 60 mg QD95.8
Dexlansoprazole MR 90 mg QD94.4

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD29.5
Dexlansoprazole MR 60 mg QD79.7
Dexlansoprazole MR 90 mg QD79.2

[back to top]

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method

Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD25.7
Dexlansoprazole MR 60 mg QD86.6
Dexlansoprazole MR 90 mg QD82.1

[back to top]

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.

Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. (NCT00255164)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD14.3
Dexlansoprazole MR 60 mg QD66.4
Dexlansoprazole MR 90 mg QD64.5

[back to top]

Mean Change From Baseline to Month 12 for PAGI-SYM Total Score

Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). (NCT00255190)
Timeframe: Baseline and Month 12

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD-1.08
Dexlansoprazole MR 90 mg QD-0.95

[back to top]

Mean Change From Baseline to Month 12 for PAGI-QOL Total Score

Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. (NCT00255190)
Timeframe: Baseline and Month 12

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD0.56
Dexlansoprazole MR 90 mg QD0.61

[back to top]

Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventiong/dL (Mean)
Dexlansoprazole MR 60 mg QD0.67
Dexlansoprazole MR 90 mg QD0.56

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Mean Change From Baseline to Month 1 for PAGI-SYM Total Score

Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). (NCT00255190)
Timeframe: Baseline and Month 1

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD-0.95
Dexlansoprazole MR 90 mg QD-0.85

[back to top]

Mean Change From Baseline to Month 1 for PAGI-QOL Total Score

Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. (NCT00255190)
Timeframe: Baseline and Month 1

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD0.54
Dexlansoprazole MR 90 mg QD0.54

[back to top]

Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmg/dL (Mean)
Dexlansoprazole MR 60 mg QD0.09
Dexlansoprazole MR 90 mg QD0.06

[back to top]

Mean Change From Baseline to Month 12 for Hemoglobin Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventiong/dL (Mean)
Dexlansoprazole MR 60 mg QD-0.29
Dexlansoprazole MR 90 mg QD-0.05

[back to top]

Mean Change From Baseline to Month 12 for Hematocrit Values

Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference. (NCT00255190)
Timeframe: Baseline and Month 12

Interventionpercentage (Mean)
Dexlansoprazole MR 60 mg QD-1.98
Dexlansoprazole MR 90 mg QD-0.93

[back to top]

Mean Change From Baseline to Month 12 for Diastolic Blood Pressure

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmm Hg (Mean)
Dexlansoprazole MR 60 mg QD4.0
Dexlansoprazole MR 90 mg QD0.6

[back to top]

Mean Change From Baseline to Month 12 for Creatinine Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmg/dL (Mean)
Dexlansoprazole MR 60 mg QD-0.04
Dexlansoprazole MR 90 mg QD-0.04

[back to top]

Mean Change From Baseline to Month 12 for Calcium Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmg/dL (Mean)
Dexlansoprazole MR 60 mg QD-0.25
Dexlansoprazole MR 90 mg QD-0.04

[back to top]

Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmg/dL (Mean)
Dexlansoprazole MR 60 mg QD0.1
Dexlansoprazole MR 90 mg QD0.0

[back to top]

Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionU/L (Mean)
Dexlansoprazole MR 60 mg QD0.9
Dexlansoprazole MR 90 mg QD0.6

[back to top]

Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionU/L (Mean)
Dexlansoprazole MR 60 mg QD0.4
Dexlansoprazole MR 90 mg QD-0.4

[back to top]

Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionU/L (Mean)
Dexlansoprazole MR 60 mg QD1.6
Dexlansoprazole MR 90 mg QD0.5

[back to top]

Mean Change From Baseline to Month 12 for White Blood Cell Count Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionWhite Blood Cell count x10 to the 3/mcL (Mean)
Dexlansoprazole MR 60 mg QD-0.20
Dexlansoprazole MR 90 mg QD0.04

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Changes From Baseline to Final Visit in Fundus Biopsy Results

Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. (NCT00255190)
Timeframe: Baseline and Final Visit (up to 12 months)

,
Interventionsubjects (Number)
Normal Baseline to Normal Final VisitNormal Baseline to Abnormal Final VisitAbnormal Baseline to Normal Final VisitAbnormal Baseline to Abnormal Final VisitUnknown Baseline to Normal Final VisitUnknown Baseline to Abnormal Final Visit
Dexlansoprazole MR 60 mg QD558172120
Dexlansoprazole MR 90 mg QD19835333523

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Changes From Baseline to Final Visit in Antrum Biopsy Results

Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal. (NCT00255190)
Timeframe: Baseline and Final Visit (up to 12 months)

,
Interventionsubjects (Number)
Normal Baseline to Normal Final VisitNormal Baseline to Abnormal Final VisitAbnormal Baseline to Normal Final VisitAbnormal Baseline to Abnormal Final VisitUnknown Baseline to Normal Final VisitUnknown Baseline to Abnormal Final Visit
Dexlansoprazole MR 60 mg QD3911212911
Dexlansoprazole MR 90 mg QD114614760114

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Mean Change From Baseline to Month 9 for PAGI-SYM Total Score

Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). (NCT00255190)
Timeframe: Baseline and Month 9

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD-1.17
Dexlansoprazole MR 90 mg QD-0.89

[back to top]

Mean Change From Baseline to Month 9 for PAGI-QOL Total Score

Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. (NCT00255190)
Timeframe: Baseline and Month 9

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD0.64
Dexlansoprazole MR 90 mg QD0.60

[back to top]

Mean Change From Baseline to Month 6 for PAGI-SYM Total Score

Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). (NCT00255190)
Timeframe: Baseline and Month 6

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD-1.05
Dexlansoprazole MR 90 mg QD-0.93

[back to top]

Mean Change From Baseline to Month 6 for PAGI-QOL Total Score

Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. (NCT00255190)
Timeframe: Baseline and Month 6

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD0.58
Dexlansoprazole MR 90 mg QD0.56

[back to top]

Mean Change From Baseline to Month 3 for PAGI-SYM Total Score

Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity). (NCT00255190)
Timeframe: Baseline and Month 3

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD-1.09
Dexlansoprazole MR 90 mg QD-0.91

[back to top]

Mean Change From Baseline to Month 3 for PAGI-QOL Total Score

Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL. (NCT00255190)
Timeframe: Baseline and Month 3

Interventionscore on a scale (Mean)
Dexlansoprazole MR 60 mg QD0.61
Dexlansoprazole MR 90 mg QD0.56

[back to top]

Mean Change From Baseline to Month 12 for Total Bilirubin Values

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmg/dL (Mean)
Dexlansoprazole MR 60 mg QD-0.02
Dexlansoprazole MR 90 mg QD-0.01

[back to top]

Mean Change From Baseline to Month 12 for Systolic Blood Pressure

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionmm Hg (Mean)
Dexlansoprazole MR 60 mg QD3.8
Dexlansoprazole MR 90 mg QD1.9

[back to top]

Mean Change From Baseline to Month 12 for Serum Gastrin Levels

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionpg/mL (Mean)
Dexlansoprazole MR 60 mg QD155.8
Dexlansoprazole MR 90 mg QD115.4

[back to top]

Mean Change From Baseline to Month 12 for Red Blood Cell Count Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionRed Blood Cell count x10 to the 6/μL (Mean)
Dexlansoprazole MR 60 mg QD-0.31
Dexlansoprazole MR 90 mg QD-0.11

[back to top]

Mean Change From Baseline to Month 12 for Pulse Rate

(NCT00255190)
Timeframe: Baseline and Month 12

Interventionbeats per minute (Mean)
Dexlansoprazole MR 60 mg QD0.5
Dexlansoprazole MR 90 mg QD-1.3

[back to top]

Mean Change From Baseline to Month 12 for Platelet Count Values

(NCT00255190)
Timeframe: Baseline and Month 12

InterventionPlatelet Count x10 to the 3/mcL (Mean)
Dexlansoprazole MR 60 mg QD-12.7
Dexlansoprazole MR 90 mg QD-1.9

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD28.6
Dexlansoprazole MR 30 mg QD96.1
Dexlansoprazole MR 60 mg QD90.9

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD57.7
Dexlansoprazole MR 30 mg QD89.3
Dexlansoprazole MR 60 mg QD86.0

[back to top]

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Days (Median)
Placebo QD71.7
Dexlansoprazole MR 30 mg QD98.9
Dexlansoprazole MR 60 mg QD96.2

[back to top]

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.

Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD14.3
Dexlansoprazole MR 30 mg QD66.4
Dexlansoprazole MR 60 mg QD66.4

[back to top]

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method

Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Subjects (Number)
Placebo QD27.2
Dexlansoprazole MR 30 mg QD74.9
Dexlansoprazole MR 60 mg QD82.5

[back to top]

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00321737)
Timeframe: 6 months

InterventionPercentage of Days (Mean)
Placebo QD36.0
Dexlansoprazole MR 30 mg QD83.3
Dexlansoprazole MR 60 mg QD78.4

[back to top]

Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00321984)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD18.5
Dexlansoprazole MR 30 mg QD54.9
Dexlansoprazole MR 60 mg QD50.0

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00321984)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD47.1
Dexlansoprazole MR 30 mg QD67.6
Dexlansoprazole MR 60 mg QD65.0

[back to top]

Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked. (NCT00321984)
Timeframe: 4 weeks

Interventionpercentage of days (Median)
Placebo QD51.7
Dexlansoprazole MR 30 mg QD80.8
Dexlansoprazole MR 60 mg QD76.9

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Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked. (NCT00321984)
Timeframe: 4 weeks

Interventionpercentage of days (Mean)
Placebo QD25.0
Dexlansoprazole MR 30 mg QD50.3
Dexlansoprazole MR 60 mg QD49.1

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Sino Nasal Outcome Test (SNOT-20)

SNOT-20 includes 20 questions combined into a total score ranging from 0 to 100 with higher numbers representing greater rhinosinusitis health burden and represents patient-reported symptom severity. (NCT00335283)
Timeframe: Baseline, 8 weeks and 16 weeks

,
InterventionScores on a Scale (Median)
Baseline8 weeks16 weeks
Lansoprazole362520
Placebo (Sugar Pill)353227

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Rhinosinusitis Outcome Measure(RSOM-31)

RSOM-31 includes 31 questions combined into a total score ranging from 0 to 155 with higher scores representing greater disease burden. Values are based on patient report. (NCT00335283)
Timeframe: Baseline, 8 weeks, and 16 weeks

,
InterventionScores on a Scale (Median)
Baseline8 weeks16 weeks
Lansoprazole634035
Placebo (Sugar Pill)513635

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Quality of Life Questionnaire (QOLRAD)

The patient-reported QOLRAD consists of 25 questions combined into a total score ranging from 25 to 175 with higher numbers representing better quality of life. (NCT00335283)
Timeframe: Baseline, 8 weeks and 16 weeks

,
InterventionScores on a Scale (Median)
Baseline8 weeks16 weeks
Lansoprazole155174173
Placebo (Sugar Pill)160155160

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Post Nasal Drainage Symptom Response

The primary outcome measure was postnasal drainage symptom response measured by using a visual analogue scale. At 8 and 16 weeks, a horizontal symptoms scale from 0% (no change) to 100% (symptoms completely resolved) was presented to participants to assess improvement in postnasal drainage symptoms. (NCT00335283)
Timeframe: 8 and 16 weeks

,
InterventionScores on a Scale (Median)
8 week16 week
Lansoprazole5550
Placebo (Sugar Pill)3.55

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Change in Lymphocyte Count

Change in mean lymphocyte count in bronchus intermedius biopsies between lansoprazole and placebo groups, measured in lymphocytes per square millimeter. Overall mean differences were compared (post-intervention mean lymphocyte count minus pre-intervention mean lymphocyte count) between the two intervention groups. (NCT00361972)
Timeframe: Baseline and 6 weeks

InterventionLymphocytes per square millimeter (Mean)
Lansoprazole-57
Placebo-3

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Log Change in Tumor Necrosis Factor (TNF) Alpha Measurement

Change in TNF alpha cytokine expression from bronchoalveolar lavage aspirate samples between lansoprazole and placebo groups, measured in log picograms per milliliter (log (pg/mL)) units, pre- and post-intervention. (NCT00361972)
Timeframe: Baseline and 6 weeks

Interventionlog (pg/mL) (Median)
Lansoprazole0.4
Placebo2.0

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Airways Reactivity (Assessed by Methacholine PC20)

Presence and degree of airway hyperresponsiveness; change from baseline to 24 weeks for airways reactivity assessed by methacholine post-diluent baseline (PC20) after medication holds (NCT00442013)
Timeframe: Measured at Weeks 0 and 24

Interventionmg/mL (Mean)
Lansoprazole Group2.6
Placebo Group2.5

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Rate of Episodes of Poor Asthma Control (EPAC)

"Episodes of poor asthma control are defined as any one of the following:~2 consecutive days with peak flow at less than 70% of baseline~prescription of oral corticosteroids for asthma~seeking urgent medical care for asthma symptoms~EPAC was measured by review of daily diaries that were maintained over the entire course of followup, i.e, 24 weeks" (NCT00442013)
Timeframe: Measured daily for 24 weeks by diary

Interventionnumber of episodes of poor asthma contrl (Number)
Lansoprazole Group230
Placebo Group184

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Asthma Symptom Utility Index (ASUI)

ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control; info obtained from questionnaire about asthma symptoms; number presents an average of the change from baseline to all follow-up points (NCT00442013)
Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

Interventionscore (Mean)
Lansoprazole Group0.86
Placebo Group0.88

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Asthma-specific Quality of Life

Scores range from 1 to 7 with higher values indicating better asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points (NCT00442013)
Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

Interventionscore (Mean)
Lansoprazole Group5.8
Placebo Group6.0

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Change in Juniper Asthma Control Score (ACS)

Score ranges from 0 to 6, a lower score indicated better asthma control. Scores above 1.5 are indicative of poor asthma control; score obtained from questionnaire with 6 questions related to asthma control and FEV (amount of air expired in the first second during a forced expiratory maneuver); number presents an average of the change from baseline to all follow-up points (NCT00442013)
Timeframe: Measured at Weeks 0, 4, 8, 12, 24

Interventionscore (Mean)
Lansoprazole Group1.1
Placebo Group1.0

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Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed at least 4 hours after last dose of short-acting bronchodilator and at least 12 hours after long-acting bronchodilator; number presents an average of the change from baseline to all follow-up points (NCT00442013)
Timeframe: Measured at Weeks 0, 4, 8, 12, 16, 20, 24

InterventionLiters (Mean)
Lansoprazole Group2.2
Placebo Group2.3

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Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar

(NCT00546117)
Timeframe: 2 months

Interventionparticipants (Number)
Prevacid1
Placebo3

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Number of Participants With Normal Type A Tympanometry

"Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure).~This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015." (NCT00546117)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Lansoprazole (Prevacid)0
Placebo0

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Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire

Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms. (NCT00546117)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Lansoprazole (Prevacid)0
Placebo0

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Acoustic Reflectometry: Level of Risk as Defined by Manufacturer

Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49-59°, moderate-high risk (level 4); 60-69°, moderate risk (level 3); 70-95°, low-moderate risk (level 2) and >95°, low risk (level 1). (NCT00546117)
Timeframe: 2 months

Interventionlevel of risk (Mean)
Lansoprazole (Prevacid)2.5
Placebo3.5

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Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear

(NCT00546117)
Timeframe: 2 months

Interventionparticipants (Number)
Prevacid1
Placebo0

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Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.

Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator. (NCT00627016)
Timeframe: 4 Weeks

InterventionPercentage of nights (Median)
Placebo35.7
Dexlansoprazole 30 mg QD73.1

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Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.

Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined. (NCT00627016)
Timeframe: Last 7 days of treatment

InterventionPercentage of participants (Number)
Placebo47.9
Dexlansoprazole 30 mg QD69.7

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Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.

Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined. (NCT00627016)
Timeframe: Last 7 days of treatment

InterventionPercentage of participants (Number)
Placebo19.6
Dexlansoprazole 30 mg QD47.5

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Symptom Score

"Total score was based on the following symptoms:~Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding~Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms." (NCT00638456)
Timeframe: Baseline and 3 Months

,
Interventionunits on a scale (Mean)
Baseline3 months
Oral Viscous Budesonide Plus Prevacid3.51.2
Placebo Plus Prevacid2.71.8

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Upper Gastrointestinal Endoscopy Score

"Endoscopy scoring tool took into account the following categories:~Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/tissue-paper mucosa Histology scoring tools Epithelial histology score Peak eosinophil count~Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease." (NCT00638456)
Timeframe: Baseline and 3 Months

,
Interventionunits on a scale (Mean)
Baseline3 months
Oral Viscous Budesonide Plus Prevacid4.61.5
Placebo Plus Prevacid7.85.4

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Number of Participants With Improvement of Espohageal Eosinophilia

Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. (NCT00638456)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Oral Viscous Budesonide Plus Prevacid13
Placebo Plus Prevacid0

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Pain Reduction

Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10). (NCT00685295)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Arm 1 / Fentora30
Arm 2 / Percocet/Prevacid24

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Occurrence of Untoward Opioid Side Effects

Subjects were monitored for any signs of untoward opioid side effects. (NCT00685295)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Arm 1 / Fentora0
Arm 2 / Percocet/Prevacid1

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Time to Analgesia

Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale) (NCT00685295)
Timeframe: 60 minutes

Interventionminutes (Median)
Arm 1 / Fentora10
Arm 2 / Percocet/Prevacid35

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)

Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.020
Gefarnate 50 mg BID-0.005

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)

Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.019
Gefarnate 50 mg BID0.015

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)

Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.027
Gefarnate 50 mg BID-0.023

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)

Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.163
Gefarnate 50 mg BID-0.036

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)

Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA
Gefarnate 50 mg BIDNA

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)

Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.064
Gefarnate 50 mg BID-0.005

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)

Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.089
Gefarnate 50 mg BID0.038

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)

Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.063
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)

Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.082
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)

Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA
Gefarnate 50 mg BIDNA

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)

Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.025
Gefarnate 50 mg BID0.020

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)

Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.051
Gefarnate 50 mg BID0.008

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)

Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.072
Gefarnate 50 mg BID0.012

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)

Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.020
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)

Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA
Gefarnate 50 mg BIDNA

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)

Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.010
Gefarnate 50 mg BID0.020

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)

Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.006
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)

Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.009
Gefarnate 50 mg BID-0.012

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)

Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID-0.071

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)

Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.333
Gefarnate 50 mg BID-1.000

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)

Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.005
Gefarnate 50 mg BID0.026

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)

Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.038
Gefarnate 50 mg BID-0.008

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)

Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.027
Gefarnate 50 mg BID-0.023

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)

Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.019
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)

Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.020
Gefarnate 50 mg BID-0.071

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Number of Participants With Adverse Events

Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings. (NCT00762359)
Timeframe: 18 Months

,
Interventionparticipants (Number)
Adverse eventAdverse event (Frequency ≥5%)Adverse event related to the study drugSerious adverse eventSerious adverse event related to the study drug
Gefarnate 50 mg BID1686825261
Lansoprazole 15 mg QD1668226270

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Number of Participants With Gastric Ulcer and/or Duodenal Ulcer

The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. (NCT00762359)
Timeframe: 18 Months

Interventionparticipants (Number)
Lansoprazole 15 mg QD6
Gefarnate 50 mg BID53

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Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)

Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. (NCT00762359)
Timeframe: 18 Months

Interventionparticipants (Number)
Lansoprazole 15 mg QD7
Gefarnate 50 mg BID56

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)

Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.027
Gefarnate 50 mg BID-0.023

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)

Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.025
Gefarnate 50 mg BID-0.030

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)

Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.005
Gefarnate 50 mg BID0.015

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)

Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.333
Gefarnate 50 mg BID-1.000

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.254
Gefarnate 50 mg BID0.136

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.132
Gefarnate 50 mg BID0.228

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.165
Gefarnate 50 mg BID0.149

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.092
Gefarnate 50 mg BID0.216

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.224
Gefarnate 50 mg BID0.205

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.150
Gefarnate 50 mg BID0.460

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Median)
Lansoprazole 15 mg QD-0.153
Gefarnate 50 mg BID0.530

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.149
Gefarnate 50 mg BID0.419

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)

Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID-0.036

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)

Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.333
Gefarnate 50 mg BIDNA

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)

Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.005
Gefarnate 50 mg BID0.010

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)

Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 9.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.018
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)

Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.020
Gefarnate 50 mg BID-0.036

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)

Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00762359)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA
Gefarnate 50 mg BIDNA

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)

The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)

The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)

The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.029
Gefarnate 50 mg BID-0.061

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)

The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID0.012

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)

The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.006
Gefarnate 50 mg BID-0.007

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)

The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)

The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)

The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.043
Gefarnate 50 mg BID-0.041

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)

The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.009
Gefarnate 50 mg BID-0.012

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)

The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.006
Gefarnate 50 mg BID0.007

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)

The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)

The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.057
Gefarnate 50 mg BID-0.204

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Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)

The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.043
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)

The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID-0.091

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)

The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.009
Gefarnate 50 mg BID-0.036

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)

The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.027
Gefarnate 50 mg BID-0.095

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)

The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.057
Gefarnate 50 mg BID0.058

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)

The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-1.000

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)

The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.056
Gefarnate 50 mg BID0.091

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)

The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.014
Gefarnate 50 mg BID-0.020

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)

The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)

The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)

The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.006
Gefarnate 50 mg BID0.014

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Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)

The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.114
Gefarnate 50 mg BID-0.102

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)

The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.000
Gefarnate 50 mg BID-0.048

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)

The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.056
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)

The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.036
Gefarnate 50 mg BID0.024

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Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)

The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.027
Gefarnate 50 mg BID0.000

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Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)

Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. (NCT00787254)
Timeframe: On occurrence (up to month 24).

Interventionparticipants (Number)
Lansoprazole 15 mg QD15
Gefarnate 50 mg BID52

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Number of Participants With Gastric Ulcer and/or Duodenal Ulcer

The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. (NCT00787254)
Timeframe: 24 Months

Interventionparticipants (Number)
Lansoprazole 15 mg QD15
Gefarnate 50 mg BID46

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Number of Participants With Adverse Events

Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings. (NCT00787254)
Timeframe: Per Incidence (up to 24 months).

,
Interventionparticipants (Number)
Adverse EventAdverse event (Frequency ≥5%)Adverse event related to the study drugSerious adverse eventSerious adverse event related to the study drug
Gefarnate 50 mg BID1256428171
Lansoprazole 15 mg QD1548328292

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)

The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.056
Gefarnate 50 mg BID0.000

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)

The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.006
Gefarnate 50 mg BID0.022

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Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)

The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.025
Gefarnate 50 mg BID-0.014

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)

The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)

The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD0.014
Gefarnate 50 mg BID-0.020

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.319
Gefarnate 50 mg BID0.188

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.114
Gefarnate 50 mg BID0.429

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.800
Gefarnate 50 mg BIDNA

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.162
Gefarnate 50 mg BID-0.278

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Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.231
Gefarnate 50 mg BID0.048

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 6.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.095
Gefarnate 50 mg BID0.047

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.102
Gefarnate 50 mg BID0.142

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.200
Gefarnate 50 mg BIDNA

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 18.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.297
Gefarnate 50 mg BID-0.056

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Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. (NCT00787254)
Timeframe: Baseline and Month 12.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.177
Gefarnate 50 mg BID0.048

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)

The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 24.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QDNA

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Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)

The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. (NCT00787254)
Timeframe: Baseline and Month 3.

Interventionscores on a scale (Mean)
Lansoprazole 15 mg QD-0.044
Gefarnate 50 mg BID0.014

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Urea Breath Test Result (DOB > 5 is Positive)After Different Time Periods From When PPI (Proton Pump Inhibitor) Was Stopped.

Negative value is defined as delta over baseline (DOB) less than 5. The subjects who were positive (DOB>=5) for H.Pylori and after PPI for 10 days repeated a breath with a negative (DOB<5) were considered false negatives. The breath test has been cleared by the FDA in a 510(k) and has > 96% accuracy. (NCT00825630)
Timeframe: 17 days

,,,
Interventionparticipants (Number)
False negatives (DOB<5) after 3 days of no PPIFalse negatives (DOB<5) after 1 day of no PPI
Esomeprazole (Nexium)01
Lansoprazole (Lanton)12
Omeprazole( Losec)34
Pantoprazole (Controloc)12

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Glycemia Control (Change in HbA1c Level)

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

InterventionPercentage (Mean)
T1D Group-1.17

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Change in Anti-GAD Autoantibody Titers

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

InterventionTiters (Mean)
T1D Group119278

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Change in Anti-IA2 Titer

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

InterventionTiters (Mean)
T1D Group-29212

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Change in C-peptide

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

Interventionng/mL (Mean)
T1D Group0.51

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Change in Insulin Dose

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

InterventionU/kg/day (Mean)
T1D Group0.02

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Change in ZnT8 Autoantibody Titer

(NCT00837759)
Timeframe: 6 months following the protocol subject's randomization/treatment initiation

InterventionTiters (Mean)
T1D Group-0.11

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Apparent Volume of Distribution (Vz/F) Pharmacokinetic Parameter.

Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz. (NCT00847210)
Timeframe: After 7 days of dosing.

InterventionL (Mean)
Dexlansoprazole MR 30 mg QD28.90
Dexlansoprazole MR 60 mg QD58.50

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AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose Pharmacokinetic Parameter.

AUC(0-24) is measure of Area Under the Curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 24 hours in this study). (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionng*hr/mL/mg (Mean)
Dexlansoprazole MR 30 mg QD2886.26
Dexlansoprazole MR 60 mg QD5119.81

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AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration Pharmacokinetic Parameter.

Area Under the Plasma Concentration Versus Time Curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]). (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionng*hr/mL/mg (Mean)
Dexlansoprazole MR 30 mg QD2842.32
Dexlansoprazole MR 60 mg QD5113.72

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Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter.

Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionng/mL (Mean)
Dexlansoprazole MR 30 mg QD691
Dexlansoprazole MR 60 mg QD1136

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Terminal Elimination Rate Constant (λz) Pharmacokinetic Parameter.

Terminal elimination rate constant (λz) is the rate at which drugs are eliminated from the body. (NCT00847210)
Timeframe: After 7 days of dosing.

Intervention1/hr (Mean)
Dexlansoprazole MR 30 mg QD0.5264
Dexlansoprazole MR 60 mg QD0.3404

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Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter.

Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionhours (Mean)
Dexlansoprazole MR 30 mg QD1.66
Dexlansoprazole MR 60 mg QD2.59

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

Tmax: Time to reach the Maximum Plasma Concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 7. (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionhours (Mean)
Dexlansoprazole MR 30 mg QD4.65
Dexlansoprazole MR 60 mg QD3.31

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Oral Clearance (CL/F) Pharmacokinetic Parameter.

CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-24), expressed in L/hr. (NCT00847210)
Timeframe: After 7 days of dosing.

Interventionliter/hr (Mean)
Dexlansoprazole MR 30 mg QD12.81
Dexlansoprazole MR 60 mg QD15.29

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.20

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.10

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.14

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.03

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.00

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.09

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Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.

PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD-0.08

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.05

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.27

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.03

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.10

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.09

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Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.

Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period. (NCT00847808)
Timeframe: Week 3 through Week 6

Interventionpercent of participants (Number)
Dexlansoprazole MR QD88

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Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.

PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life. (NCT00847808)
Timeframe: Baseline and Week 6.

Interventionunits on a scale (Mean)
Dexlansoprazole MR QD0.02

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Pharmacodynamic Parameter Maximum Platelet Aggregation (MPA) From Aggregometry (Turbidimetric) With 5 µM Adenosine Diphosphate.

Maximum platelet aggregation (MPA) from aggregometry (turbidimetric) with 5 µM adenosine diphosphate. (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercentage of MPA (Mean)
PPI Group 1: Regimen A28.1
PPI Group 1: Regimen B30.8
PPI Group 2: Regimen A34.6
PPI Group 2: Regimen C36.2
PPI Group 3: Regimen A34.2
PPI Group 3: Regimen D42.5
PPI Group 4: Regimen A29.3
PPI Group 4: Regimen E38.2

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Pharmacodynamic Parameter MPA From Aggregometry (Turbidimetric) With 20 µM Adenosine Diphosphate.

MPA from aggregometry (turbidimetric) with 20 µM adenosine diphosphate. (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercentage of MPA (Mean)
PPI Group 1: Regimen A36.7
PPI Group 1: Regimen B41.6
PPI Group 2: Regimen A43.1
PPI Group 2: Regimen C46.3
PPI Group 3: Regimen A43.5
PPI Group 3: Regimen D53.5
PPI Group 4: Regimen A39.3
PPI Group 4: Regimen E47.9

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Pharmacodynamic Parameter Platelet Reactivity Index (PRI) From Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation State (Flow Cytometry).

PRI is the platelet reactivity index from VASP phosphorylation state (flow cytometry). (NCT00942175)
Timeframe: 24-hour post Day 9 dose in each period.

Interventionpercent inhibition (Mean)
PPI Group 1: Regimen A42.3
PPI Group 1: Regimen B46.4
PPI Group 2: Regimen A41.3
PPI Group 2: Regimen C43.0
PPI Group 3: Regimen A47.9
PPI Group 3: Regimen D59.1
PPI Group 4: Regimen A46.5
PPI Group 4: Regimen E58.0

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Pharmacokinetic Parameter Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]) of Clopidogrel's Active Metabolite.

Area under the plasma concentration versus time curve (AUC(0-tlqc)) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]). (NCT00942175)
Timeframe: Day 9 of each period

Interventionng*hr/ML (Mean)
PPI Group 1: Regimen A41.69
PPI Group 1: Regimen B36.42
PPI Group 2: Regimen A41.25
PPI Group 2: Regimen C37.75
PPI Group 3: Regimen A37.78
PPI Group 3: Regimen D26.28
PPI Group 4: Regimen A42.35
PPI Group 4: Regimen E31.23

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Pharmacokinetic Parameter Peak Plasma Concentration (Cmax) of Clopidogrel's Active Metabolite.

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT00942175)
Timeframe: Day 9 of each period

Interventionng/mL (Mean)
PPI Group 1: Regimen A39.14
PPI Group 1: Regimen B30.01
PPI Group 2: Regimen A38.85
PPI Group 2: Regimen C29.33
PPI Group 3: Regimen A38.25
PPI Group 3: Regimen D22.55
PPI Group 4: Regimen A40.98
PPI Group 4: Regimen E24.69

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Percentage of Participants Completely Cured of Reflux Esophagitis Evaluated by Endoscopy Based on CYP2C19

Reflux esophagitis evaluated by endoscopy as per LA Classification graded as: A=1 or more mucosal breaks no longer than 5 millimeter (mm) that did not extend between tops of 2 mucosal folds, B=1 or more mucosal breaks more than 5 mm long that did not extend between tops of 2 mucosal folds, C=1 or more mucosal break continuous between the tops of 2 or more mucosal folds but involves less than 75 percent of circumference, D=1 or more mucosal break involving at least 75 percent of circumference. Participants that were not categorized in any of the above mentioned grades (A to D) were considered as cured of reflux esophagitis. Participants were classified as CYP2C19 homozygous extensive, heterozygous extensive and poor metabolizers. (NCT01008696)
Timeframe: Day 57

,
InterventionPercentage of participants (Number)
Homozygous Extensive Metabolizer (n=42, 35)Heterozygous Extensive Metabolizer (n=30, 38)Poor Metabolizer (n=15, 18)
Lansoprazole93.94100.00100.00
Rabeprazole97.37100.0093.33

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Change From Baseline in Symptoms of Reflux Esophagitis Evaluated by the Symptom Assessment Questionnaire

Gastroesophageal reflux disease and abdominal GI-related symptoms (heartburn, regurgitation, globus sensation, chronic cough, epigastric pain, non cardiac chest pain, hoarseness, dysphagia, abdominal distension, bloating, post-prandial discomfort, early satiety, nausea, vomiting, belching) experienced by participants were assessed and graded into 4 categories: 0 (Nothing)=No symptom, 1 (Mild)=A little but not uncomfortable, 2 (Moderate)=Present but interfering daily life activities a little, 3 (Severe)=Very uncomfortable, interfering daily life activities or sleeping. (NCT01008696)
Timeframe: Baseline and Day 57

,
InterventionUnits on a scale (Mean)
Baseline: Heartburn (n=87, 91)Baseline:Regurgitation (n=87, 91)Baseline: Globus sensation (n=87, 91)Baseline: Chronic cough (n=87, 91)Baseline: Epigastric pain (n=87, 90)Baseline: Non cardiac chest pain (n=85, 90)Baseline: Hoarseness (n=87, 90)Baseline: Dysphagia (n=87, 91)Baseline: Abdominal distension (n=87, 91)Baseline: Bloating (n=87, 90)Baseline: Post-prandial discomfort (n=87, 91)Baseline: Early satiety (n=86, 91)Baseline: Nausea (n=87, 91)Baseline: Vomiting (n=87, 91)Baseline: Belching (n=87, 91)Change at Day 57: Heartburn (n=87, 91)Change at Day 57: Regurgitation (n=87, 91)Change at Day 57: Globus sensation (n=87, 91)Change at Day 57: Chronic cough (n=87, 91)Change at Day 57: Epigastric pain (n=87, 90)Change at Day 57:Non cardiac chest pain (n=85, 90)Change at Day 57: Hoarseness (n=87, 90)Change at Day 57: Dysphagia (n=87, 91)Change at Day 57: Abdominal distension (n=87, 91)Change at Day 57: Bloating (n=87, 90)Change at Day57:Post-prandial discomfort (n=87,91)Change at Day 57: Early satiety (n=86, 91)Change at Day 57: Nausea (n=87, 91)Change at Day 57: Vomiting (n=87, 91)Change at Day 57: Belching (n=87, 91)
Lansoprazole0.590.930.820.300.940.260.220.220.590.440.550.250.130.020.36-0.54-0.84-0.32-0.21-0.77-0.20-0.17-0.14-0.40-0.37-0.35-0.16-0.11-0.02-0.29
Rabeprazole0.610.980.550.340.910.330.230.160.610.550.530.270.160.080.38-0.55-0.89-0.31-0.22-0.77-0.28-0.14-0.11-0.38-0.41-0.45-0.21-0.16-0.08-0.25

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Overall Assessment of Study Medication by Investigator

Investigator's overall assessment of study medication based on the global symptom assessment was measured. The assessment was categorized as: 2=very good, 1=good, 0=as usual, -1=bad and -2=very bad. (NCT01008696)
Timeframe: Day 57

InterventionUnits on a scale (Mean)
Rabeprazole1.37
Lansoprazole1.43

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Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Heartburn After the Heartburn-inducing Meals

"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe" (NCT01037452)
Timeframe: 1 day

Interventionmillimeters (Mean)
Combination Product69.3
PPI Alone61.2
Antacid Alone59.1
Placebo56.9

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Measure: Maximum Heartburn Intensity for Those Participants Who Experience Any Nighttime Heartburn

"Heartburn severity was measured using a Visual Analog Scale, which was 100 milliimeters long.~0 millimeters: None (no heartburn) 100 millimeters: Most severe" (NCT01037452)
Timeframe: 1 day

Interventionmillimeters (Mean)
Combination Product8.2
PPI Alone7.0
Antacid Alone4.7
Placebo4.0

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Measure: Number of Participants That Reported an Adverse Event for the Combination Product, PPI Alone, Antacid Alone and Placebo.

(NCT01037452)
Timeframe: 1 day

Interventionparticipants (Number)
Combination Product0
PPI Alone1
Antacid Alone0
Placebo0

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Measure: Number of Participants With no Heartburn (Post Treatment) Following Consumption of Heartburn-inducing Meal

Participant reported severity of heartburn using a Visual Analog Scale (VAS)directly on CRF every 15 minutes until no heartburn reported or up to 5 hours after 1st heartburn-inducing meal, whichever occurred first. At this point in time, a diary was provided to participants to record any changes in severity of heartburn for 28 hours post treatment. (NCT01037452)
Timeframe: 1 day

Interventionparticipants (Number)
Combination Product0
PPI Alone2
Antacid Alone1
Placebo0

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Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24)/Dose)

AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng*hr/mL/mg (Mean)
Dexlansoprazole 15 mg QD143.2
Dexlansoprazole 30 mg QD87.6
Dexlansoprazole 60 mg QD55.5

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Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc))

AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng*hr/mL (Mean)
Dexlansoprazole 15 mg QD1914
Dexlansoprazole 30 mg QD2892
Dexlansoprazole 60 mg QD3747

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Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose (AUC(0-24))

AUC(0-24) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval (24 hours), calculated using the linear trapezoidal rule. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng*hr/mL (Mean)
Dexlansoprazole 15 mg QD2149
Dexlansoprazole 30 mg QD2628
Dexlansoprazole 60 mg QD3330

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Time to Reach the Peak Plasma Concentration (Tmax)

Time to reach the maximum plasma concentration (Cmax) of Dexlansoprazole, equal to time (hours) to Cmax, as observed on Day 7. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionhours (Mean)
Dexlansoprazole 15 mg QD4.4
Dexlansoprazole 30 mg QD4.1
Dexlansoprazole 60 mg QD4.1

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The Peak Plasma Concentration (Cmax)

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng/mL (Mean)
Dexlansoprazole 15 mg QD559
Dexlansoprazole 30 mg QD1005
Dexlansoprazole 60 mg QD964

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Dose-normalized Peak Plasma Concentration (Cmax/Dose)

Maximum observed plasma concentration (the peak plasma concentration of a drug after administration), normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng/mL/mg (Mean)
Dexlansoprazole 15 mg QD37.3
Dexlansoprazole 30 mg QD33.5
Dexlansoprazole 60 mg QD16.1

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Dose-normalized Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration (AUC(0-tlqc)/Dose)

AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (tlqc), calculated using the linear trapezoidal rule, and normalized by dose. Pharmacokinetic parameters were derived using noncompartmental methods from the plasma concentrations of dexlansoprazole. (NCT01045096)
Timeframe: Day 7 after 7 days of dosing with dexlansoprazole delayed release capsules.

Interventionng*hr/mL/mg (Mean)
Dexlansoprazole 15 mg QD128
Dexlansoprazole 30 mg QD96
Dexlansoprazole 60 mg QD62

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf. (NCT01045967)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)2253.776
Reference (Prevacid®)2195.918

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT01045967)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)2156.104
Reference (Prevacid®)2130.082

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT01045967)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng/mL (Mean)
Test (Lansoprazole)939.025
Reference (Prevacid®)865.678

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf. (NCT01046084)
Timeframe: Blood samples collected over a 14 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)1060.923
Reference (Prevacid®)938.857

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT01046084)
Timeframe: Blood samples collected over a 14 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)979.389
Reference (Prevacid®)890.06

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT01046084)
Timeframe: Blood samples collected over a 14 hour period.

Interventionng/mL (Mean)
Test (Lansoprazole)272.038
Reference (Prevacid®)238.043

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Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Cmax. (NCT01046253)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng/mL (Mean)
Test (Lansoprazole)782.438
Reference (Prevacid®)738.531

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AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on AUC0-inf. (NCT01046253)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)1998.063
Reference (Prevacid®)2052.519

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AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on AUC0-t. (NCT01046253)
Timeframe: Blood samples collected over a 12 hour period.

Interventionng*h/mL (Mean)
Test (Lansoprazole)1938.669
Reference (Prevacid®)1982.598

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Change in Inflammation Biomarker Tissue PGE2 Level

Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay (NCT01093755)
Timeframe: 3 months, 6 months

,
Interventionnanograms/gram of tissue (Mean)
Change from baseline at 3 monthsChange from baseline at 6 months
Dexlansoprazole1.351.19
Omeprazole-0.02-0.06

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Change in Esophageal Inflammation Biomarker COX-2 Gene Expression

Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot. (NCT01093755)
Timeframe: 3 months, 6 months

,
Intervention% of tubulin (Mean)
Change from baseline at 3 monthsChange from baseline at 6 months
Dexlansoprazole36.8156.54
Omeprazole27.1725.49

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Change From Baseline in Average Antrum Chronic Inflammation Score

Chronic inflammation of the antrum was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe (NCT01135368)
Timeframe: Baseline and Year 5

Interventionscores on a scale (Mean)
Baseline (n=473)Change from Baseline (n=353)
Lansoprazole0.8-0.2

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Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Right Eye

The macula lutea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data49101
Normal7531720
Pathological4327

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Change From Baseline in Ophthalmologic Examination - Assessment of Macula Lutea of the Left Eye

The macula lutea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as maculopathy, retinal pigmentation, macular degeneration, diabetic retinopathy, retinal hemorrhage or aneurysm. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in macula lutea classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46101
Normal7732318
Pathological4522

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Change From Baseline in Ophthalmologic Examination - Adaptation Without Glare

"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation without glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation without glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,,
Interventionparticipants (Number)
Year 5: Missing dataYear 5: Decreased due to ageYear 5: PathologicalYear 5: Normal
Decreased Due to Age1402
Missing Data620130
Normal73114288
Pathological401016

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Change From Baseline in Corpus Chronic Inflammation Score

Chronic inflammation of the corpus was assessed by histopathology and graded according to the Sydney classification: 0 = None; 1 = mild; 2 = moderate; 3 = Severe. (NCT01135368)
Timeframe: Baseline and Year 5

Interventionscores on a scale (Mean)
Baseline (n=476)Change from Baseline (n=363)
Lansoprazole0.4-0.0

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Change From Baseline in Enterochromaffin-like Cell Hyperplasia

"Enterochromaffin-like (ECL) cells were evaluated and classified by histopathological examinations as Normal, Simple (diffuse) hyperplasia, or Linear, chain producing hyperplasia.~The shift table below summarizes the individual transitions in ECL-cell classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows) for all patients." (NCT01135368)
Timeframe: Baseline and Year 5

,,,
Interventionparticipants (Number)
Year 5: NormalYear 5: Simple hyperplasiaYear 5: Linear hyperplasiaYear 5: No data
Linear1000
No Data264214
Normal3151013108
Simple8203

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Change From Baseline in Ophthalmologic Examination - Adaptation With Glare

"Adaptation is the ability of the eye to adjust to various levels of darkness and light. Normal and pathological status of adaptation with glare was defined as follows:~Normal status: Contrast between 1:0.05 and 1:23.5.~Pathological status: Contrast = 0 or contrast > 1:23.5.~The shift table below summarizes the individual transitions in the classification of adaptation with glare between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,,
Interventionparticipants (Number)
Year 5: Missing dataYear 5: Decreased due to ageYear 5: PathologicalYear 5: Normal
Decreased Due to Age2402
Missing Data752833
Normal58118251
Pathological1201624

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Change From Baseline in Ophthalmologic Examination - Accommodation

Accommodation is the adjustment of the focal length of the eye lens to keep an object in focus on the retina as its distance from the eye varies, and is measured in diopters: Diopters = 1/(focal length). (NCT01135368)
Timeframe: Baseline and Year 5

Interventiondiopters (Mean)
Right Eye: Baseline (n=424)Right Eye: Change from Baseline (n=348)Left Eye: Baseline (n=426)Left Eye: Change from Baseline (n=349)
Lansoprazole2.877-0.0902.835-0.073

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Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Right Eye

The retinal blood vessels of the right eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data4874
Normal6827922
Pathological12660

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Change From Baseline in Endoscopic Healing of Erosive Reflux Disease as Assessed by Endoscopy

Los Angeles Classification is used to grade the extension of changes in the oesophagus induced by reflux disease (Grade 0: normal aspect of mucosa; Grade A: ≥1 mucosal breaks no longer than 5 mm; Grade B: ≥1 mucosal breaks >5 mm long; Grade C: mucosal breaks extending between tops of two or more mucosal folds but are <75% of the circumference; Grade D: mucosal breaks ≥75% of the circumference). Healed defined as anything less than Grade A criteria. The shift table below summarizes the individual transitions in Los Angeles classification between Baseline (table columns) and Week 8 (table rows). (NCT01135368)
Timeframe: Baseline and Week 8

,,,,
Interventionparticipants (Number)
Week 8: Grade 0Week 8: Grade AWeek 8: Grade BWeek 8: Grade CWeek 8: No data
Grade 038000130
Grade A97170035
Grade B79193017
Grade C1761114
Grade D42110

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Change From Baseline in Antrum Atrophy

Atrophy was assessed by histopathological examination of cells biopsied from the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,,,
Interventionparticipants (Number)
Year 5: No atrophyYear 5: Mild atrophyYear 5: Moderate atrophyYear 5: Severe atrophyYear 5: No data
Mild2315028
Moderate41101
No Atrophy30674091
No Data232017
Severe10000

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Change From Baseline in Antrum Intestinal Metaplasia

Intestinal metaplasia was assessed by biopsy and histopathological examination of the antrum and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,,
Interventionparticipants (Number)
Year 5: NoneYear 5: MildYear 5: ModerateYear 5: SevereYear 5: No data
Mild1321012
Moderate42100
No Data232107
None319650108

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Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Blood Vessels of the Left Eye

The retinal blood vessels of the left eye were assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as retinal vascular disorder, retinopathy, and retinal hemorrhage. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal blood vessel classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data4674
Normal6827823
Pathological13760

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Change From Baseline in Ophthalmologic Examination - Color Vision

Color vision was assessed by an Ophthalmologist and classified as normal or pathological. Pathological findings include abnormal color vision tests, color blindness and anomalous quotient. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in color vision classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46120
Normal7632010
Pathological51027

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Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Right Eye

The retinal aspect of the right eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data48110
Normal803562
Pathological018

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Ophthalmologic Examination - Visual Acuity

Visual Acuity was measured using the Snellen eye chart at a distance of 6 meters. Acuity is expressed as a ratio of the test distance (6 M) / the distance the average eye can see the letters on a certain line of the eye chart. Visual acuity of 1 is normal; an individual with acuity of 0.5 could only recognize an object at half the distance compared to an individual with normal acuity. (NCT01135368)
Timeframe: Baseline and Year 5

Interventionratio (Mean)
Right Eye: Acuity at Baseline (n=443)Right Eye: Acuity at Year 5 (n=376)Left Eye: Acuity at Baseline (n=447)Left Eye: Acuity at Year 5 (n=379)
Lansoprazole0.9270.9040.9190.894

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Change From Baseline in Corpus Intestinal Metaplasia

Intestinal metaplasia was assessed by biopsy and histopathological examination of the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in intestinal metaplasia classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: NoneYear 5: MildYear 5: ModerateYear 5: SevereYear 5: No data
Mild12001
No Data1801011
None359100112

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Change From Baseline in Ophthalmologic Examination - Assessment of Retinal Aspect of the Left Eye

The retinal aspect of the left eye (such as color anomalies) was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as deep red ocular fundus, fundus myopicus, retinal disorders, exudates or pigmentation. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in retinal aspect classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46110
Normal803611
Pathological115

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Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Right Eye

The optic nerve and papilla of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data48110
Normal763379
Pathological4417

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Change From Baseline in Ophthalmologic Examination - Assessment of Optic Nerve and Papilla of the Left Eye

The optic nerve and papilla of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as optic nerve cupping, optic nerve cup/disc ratio, or glaucomatous optic disc atrophy. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in optic nerve/papilla classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46110
Normal753398
Pathological6417

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Change From Baseline in Reflux Disease Symptom - Difficulty Swallowing

Difficulty swallowing symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild899004
Moderate335115
None29373013
Severe132112

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Change From Baseline in Reflux Disease Symptoms - Acid Regurgitation

Acid regurgitation symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild11319004
Moderate125282110
None584103
Severe8122308

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Change From Baseline in Reflux Disease Symptom - Pain in Upper Abdomen

Pain in the upper abdomen symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild12519407
Moderate86212110
None1249006
Severe4410833

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Change From Baseline in Reflux Disease Symptom - Nausea & Vomiting

Nausea and vomiting symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild7891010
Moderate259200
None303102015
Severe132201

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Change From Baseline in Reflux Disease Symptom - Heartburn

Heartburn symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild597003
Moderate11727408
Severe1864312214

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Change From Baseline in Blood Analysis - Follicle Stimulating Hormone

The change between follicle stimulating hormone (FSH) measured at year 5 in males including final visit and follicle stimulating hormone measured at baseline. (NCT01135368)
Timeframe: Baseline and Year 5.

InterventionIU/L (Mean)
Baseline (n=286)Change from Baseline (n=214)
Lansoprazole7.620.39

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Change From Baseline in Reflux Disease Symptom - Cough & Sore Throat

Cough and sore throat symptoms were assessed by the Investigator at Baseline and the Week 8 visit. The shift table below summarizes the individual transitions in symptom intensity (mild, moderate, severe or none) between Baseline (depicted in the columns) and Week 8 (depicted in the rows) for all patients. (NCT01135368)
Timeframe: Baseline and Week 8

,,,
Interventionparticipants (Number)
Week 8 Symptoms: NoneWeek 8 Symptoms: MildWeek 8 Symptoms: ModerateWeek 8 Symptoms: SevereWeek 8 Missing data
Mild714303
Moderate247004
None305163019
Severe146201

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Change From Baseline in Blood Analysis - Luteinizing Hormone

The change between luteinizing hormone measured at year 5 in males including final visit and luteinizing hormone measured at baseline. (NCT01135368)
Timeframe: Baseline and Year 5

InterventionIU/L (Mean)
Baseline (n=286)Change from Baseline (n=214)
Lansoprazole4.730.71

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Change From Baseline in Blood Analysis - Testosterone

The change between testosterone measured at year 5 in males including final visit and Testosterone measured at baseline. (NCT01135368)
Timeframe: Baseline and Year 5

Interventionµg/L (Mean)
Baseline (n=285)Change from Baseline (n=214)
Lansoprazole4.570.16

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Change From Baseline in Corpus Atrophy

Atrophy was assessed by histopathological examination of cells biopsied from the corpus and classified according to the Sydney classification as mild, moderate, severe or none. The shift table below summarizes the individual transitions in atrophy classification (mild, moderate, severe or none) between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,,
Interventionparticipants (Number)
Year 5: No atrophyYear 5: Mild atrophyYear 5: Moderate atrophyYear 5: Severe atrophyYear 5: No data
Mild120218
Moderate10100
No Atrophy330970105
No Data1710111

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Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Right Eye

"The vitreous body of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46110
Normal7333811
Pathological8217

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Change From Baseline in Ophthalmologic Examination - Vitreous Body Assessment of Left Eye

"The vitreous body of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as myodesopsia, vitreous opacities, degeneration, detachment or prolapse. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in vitreous body classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data47120
Normal733417
Pathological7316

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Change From Baseline in Ophthalmologic Examination - Lens Assessment of Right Eye

"The lens of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data4683
Normal5619344
Pathological257124

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Change From Baseline in Ophthalmologic Examination - Lens Assessment of Left Eye

"The lens of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5.~Pathological classification includes abnormal findings such as cataracts, lenticular opacities, vacuoles or pseudophakia. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in lens classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows)." (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data4665
Normal5619343
Pathological258124

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Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Right Eye

The cornea of the right eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46110
Normal783434
Pathological3516

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Change From Baseline in Ophthalmologic Examination - Cornea Assessment of Left Eye

The cornea of the left eye was assessed by an Ophthalmologist and judged to be normal or pathological at Baseline and at Year 5. Pathological classification includes abnormal findings such as cataracts, corneal degeneration, opacity, scars or deposits. Normal indicates no pathological findings were observed. The shift table below summarizes the individual transitions in corneal classification between Baseline (depicted in the columns) and Year 5 (depicted in the rows). (NCT01135368)
Timeframe: Baseline and Year 5

,,
Interventionparticipants (Number)
Year 5: No dataYear 5: NormalYear 5: Pathological
No Data46110
Normal773484
Pathological4511

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2 Hour C-peptide AUC in Response to MMTT

Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90, and 120 minutes post-meal. (NCT01155284)
Timeframe: Month 6

Interventionpmol/L (Median)
Sitagliptin and Lansoprazole485
Placebo675

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2 Hour C-peptide AUC in Response to MMTT

Blood samples for C-peptide were collected at baseline (pre-meal) and 15, 30, 60, 90 and 120 minutes post-meal. (NCT01155284)
Timeframe: Month 12

Interventionpmol/L (Median)
Sitagliptin and Lansoprazole358
Placebo495

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Change in Reflux Symptom Index (RSI)

The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of >13 is considered to be abnormal. (NCT01317472)
Timeframe: Baseline to 2 months

Interventionunits on a scale (Mean)
Dexlansoprazole18
Sugar Pill13

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Number of Participants With Eosinophilic Esophagitis

(NCT01404832)
Timeframe: 8 weeks

Interventionparticipants (Number)
Patients Whose PPI Was Changed to Lansoprazole0

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Number of Patients Who Had Resolution of Heartburn With Lansoprazole

Resolution of heartburn defined as >50% improvement in symptoms (NCT01404832)
Timeframe: After 8 weeks of treatment

Interventionparticipants (Number)
Patients Whose PPI Was Changed to Lansoprazole9

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The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment

Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary. (NCT01642602)
Timeframe: 4 weeks

InterventionPercentage of days (Median)
Dexlansoprazole 30 mg47.3

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Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period

A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug. (NCT01642602)
Timeframe: 4 weeks

InterventionPercentage of participants (Number)
DiarrhoeaHeadache
Dexlansoprazole 30 mg6.76.7

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Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose. (NCT01642615)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
DiarrhoeaNasopharyngitisHeadacheOropharyngeal pain
Healing Phase: Dexlansoprazole 60 mg6.56.512.98.1

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Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose. (NCT01642615)
Timeframe: From Week 8 to Week 24

,
Interventionpercentage of participants (Number)
Abdominal painAbdominal pain upperErosive oesophagitisDiarrhoeaPyrexiaNasopharyngitisPharyngitisSinusitisUpper respiratory tract infectionBronchitisHeadacheInsomnia
Maintenance Phase: Dexlansoprazole 30 mg12.04.04.00.00.012.012.012.08.08.024.08.0
Maintenance Phase: Placebo11.57.77.77.77.715.40.00.00.03.815.40.0

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Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8

Healing of EE was assessed by endoscopy. (NCT01642615)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Healing Phase: Dexlansoprazole 60 mg87.9

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Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24

Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy. (NCT01642615)
Timeframe: From Week 8 to Week 24

Interventionpercentage of participants (Number)
Maintenance Phase: Dexlansoprazole 30 mg81.8
Maintenance Phase: Placebo58.3

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Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24

The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%. (NCT01642615)
Timeframe: Weeks 8 to 24

Interventionpercent of days (Mean)
Maintenance Phase: Dexlansoprazole 30 mg76.7
Maintenance Phase: Placebo68.9

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Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment

Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%. (NCT01642615)
Timeframe: 8 weeks

Interventionpercent of days (Mean)
Healing Phase: Dexlansoprazole 60 mg59.6

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Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]

Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
100-mg LY2940680 Capsule (Fasted)9460
100-mg LY2940680 Tablet (Fasted)10300
100-mg LY2940680 Tablet (Fed)11300
100-mg LY2940680 Tablet (Fasted) PPI10000

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Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)

Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

Interventionhours (h) (Median)
50-mg LY2940680 Capsule (Fasted)1.5
100-mg LY2940680 Capsule (Fasted)2
200-mg LY2940680 Capsule (Fasted)2
400-mg LY2940680 Capsule (Fasted)2

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Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)

The Cmax of LY2940680 during Part A of the study was reported. (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
50-mg LY2940680 Capsule (Fasted)622
100-mg LY2940680 Capsule (Fasted)661
200-mg LY2940680 Capsule (Fasted)1740
400-mg LY2940680 Capsule (Fasted)3360

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Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]

Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
50-mg LY2940680 Capsule (Fasted)5300
100-mg LY2940680 Capsule (Fasted)9440
200-mg LY2940680 Capsule (Fasted)22800
400-mg LY2940680 Capsule (Fasted)49300

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Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]

Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)] (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
50-mg LY2940680 Capsule (Fasted)5340
100-mg LY2940680 Capsule (Fasted)9530
200-mg LY2940680 Capsule (Fasted)23000
400-mg LY2940680 Capsule (Fasted)49800

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Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs

Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section. (NCT01681186)
Timeframe: Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)

,,,,,,,,
InterventionParticipants (Count of Participants)
Adverse Events (AEs)Serious Adverse Events (SAEs)
100-mg LY2940680 Capsule (Fasted) Part A40
100-mg LY2940680 Capsule (Fasted) Part B60
100-mg LY2940680 Tablet (Fasted)50
100-mg LY2940680 Tablet (Fed)50
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)30
200-mg LY2940680 Capsule (Fasted)30
400-mg LY2940680 Capsule (Fasted)30
50-mg LY2940680 Capsule (Fasted)30
Placebo Capsule (Fasted)20

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Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)

Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax) (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug

Interventionhours (h) (Median)
100-mg LY2940680 Capsule (Fasted)1
100-mg LY2940680 Tablet (Fasted)1.5
100-mg LY2940680 Tablet (Fed)3
100-mg LY2940680 Tablet (Fasted) PPI1

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Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation

The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study. (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
100-mg LY2940680 Capsule (Fasted)879
100-mg LY2940680 Tablet (Fasted)1170
100-mg LY2940680 Tablet (Fed)776
100-mg LY2940680 Tablet Plus 30-mg Lansoprazole (Fasted)1290

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Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]

Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)] (NCT01681186)
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug

Interventionnanograms*hours per milliliter (ng*h/mL) (Geometric Mean)
100-mg LY2940680 Capsule (Fasted)9390
100-mg LY2940680 Tablet (Fasted)10300
100-mg LY2940680 Tablet (Fed)11200
100-mg LY2940680 Tablet (Fasted) PPI9980

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Subjective Symptom Improvement Rate

"Subjective symptoms were evaluated as Disappeared, Improved, No change, Worsened, or Unclear. These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of Disappeared + Improved) was calculated for each symptom. The percentage of participants with Improvement by symptom was reported." (NCT01990339)
Timeframe: Start of treatment and Week 4

Interventionpercentage of participants (Number)
HeartburnAcid regurgitationPostorandial fullnessEarly satietyEpigastric painEpigastric burningUpper abdominal bloatingNausea/vomitingBelching
Lansoprazole75.773.568.665.369.173.064.866.461.6

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Frequency of Adverse Events (Adverse Drug Reactions)

Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported. (NCT01990339)
Timeframe: 4 Weeks

Interventionpercentage of participants (Number)
Adverse drug reaction(s)DiarrhoeaUrticariaRashConstipationNauseaAbdominal distensionStomatitisDizzinessDysgeusiaHeadacheDrug eruptionFeeling abnormalHypoaesthesiaSomnolenceDyspnoeaOropharyngeal discomfortPruritusPruritus generalisedPalpitationsAbdominal painAbdominal pain lowerChange of bowel habitMeteorismGastrooesophageal reflux diseaseOral discomfortOral mucosal eruptionAbdominal discomfortChest painFace oedemaOedemaThirstDecreased appetiteBack painSleep disorderCoughAcneEczemaErythema multiformeToxic skin eruptionHot flush
Lansoprazole0.690.160.080.070.040.040.020.020.020.020.020.020.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.010.01

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AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5

AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration. (NCT02064907)
Timeframe: Day 5 predose and up to 24 hours post-dose

Interventionng*hr/mL (Mean)
Dexlansoprazole OD Tablets5818.8236
Dexlansoprazole Capsules7184.1729

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AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5

AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours). (NCT02064907)
Timeframe: Day 5 predose and up to 24 hours post-dose

Interventionng*hr/mL (Mean)
Dexlansoprazole OD Tablets5824.7108
Dexlansoprazole Capsules7196.1922

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Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT02064907)
Timeframe: Day 1 predose and up to 24 hours post-dose

Interventionng/mL (Mean)
Dexlansoprazole OD Tablets1046.8846
Dexlansoprazole Capsules1164.3654

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Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5

Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT02064907)
Timeframe: Day 5 predose and up to 24 hours post-dose

Interventionng/mL (Mean)
Dexlansoprazole OD Tablets1150.8462
Dexlansoprazole Capsules1178.1346

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AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1

AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration. (NCT02064907)
Timeframe: Day 1 predose and up to 24 hours post-dose

Interventionng*hr/mL (Mean)
Dexlansoprazole OD Tablets5059.5689
Dexlansoprazole Capsules6746.6075

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AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1

AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity. (NCT02064907)
Timeframe: Day 1 predose and up to 24 hours post-dose

Interventionng*hr/mL (Mean)
Dexlansoprazole OD Tablets5364.0217
Dexlansoprazole Capsules7155.4994

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Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets

The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests. (NCT02096458)
Timeframe: Day 1

InterventionSeconds (Mean)
Dexlansoprazole36.0

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Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
Takepron Capsule or OD Tablet 15 mgTakepron Capsule or OD Tablet 30 mgRabeprazole tablet 10 mgH2 receptor antagonist (oral)Omeprazole (injection)H2 receptor antagonist (injection)Other peptic ulcer drugsEndoscopic hemostasisOther
Lansoprazole 15 mg1522121215

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Frequency of Adverse Drug Reactions

Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. (NCT02099682)
Timeframe: 12 months

Interventionparticipants (Number)
Enteritis infectiousLymphomaDiabetes mellitusAnxietyDizzinessDysgeusiaHeadacheLoss of consciousnessSudden hearing lossAbdominal discomfortAbdominal distensionAbdominal painColitisConstipationDiarrhoeaEnterocolitisGastrooesophageal reflux diseaseHaematocheziaNauseaColitis microscopicHypoaesthesia oralFaeces softDrug eruptionEczemaHypersensitivity vasculitisPruritusRash generalisedBack painOsteoporosisRenal failure chronicSudden deathThirstHepatic enzyme increasedGlycosylated haemoglobin increasedWeight decreasedFallSpinal fracture
Lansoprazole 15 mg11112111111112231114311311111111111111

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Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion

Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
PresentAbsent
Lansoprazole 15 mg318624

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Presence of Gastric or Duodenal Hemorrhagic Lesion

Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
PresentAbsent
Lansoprazole 15 mg32019

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Treatment for Gastric/Duodenal Ulcer or Lesion

Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
PresentAbsent
Lansoprazole 15 mg024

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Presence or Absence of Endoscopic Examinations

Summary of data on the presence or absence of endoscopic examinations. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
With endoscopyWithout endoscopy
Lansoprazole 15 mg2773437

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Presence of Gastric or Duodenal Ulcer

Summary of data on the presence or absence of gastric or duodenal ulcers. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
PresentAbsent
Lansoprazole 15 mg319020

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Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. (NCT02099682)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
Takepron 15 mg: RecoveryTakepron 15 mg: ReliefTakepron 30 mg: RecoveryTakepron 30 mg: ReliefRabeprazole 10 mg: RecoveryRabeprazole 10 mg: ReliefH2 receptor antagonist (orally): RecoveryH2 receptor antagonist (orally): ReliefOmeprazole (injection): RecoveryOmeprazole (injection): ReliefH2 receptor antagonist (injection): RecoveryH2 receptor antagonist (injection): ReliefOther peptic ulcer drugs: RecoveryOther peptic ulcer drugs: ReliefEndoscopic hemostasis: RecoveryEndoscopic hemostasis: ReliefOther: RecoveryOther: Relief
Lansoprazole 15 mg961111111121329611

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Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions. (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
Takepron 15 mg - ResolvingTakepron 15 mg - UnknownTakepron 30 mg - ResolvedRabeprazole 10 mg _ResolvedRabeprazole 20 mg - ResolvedH2 receptor antagonist - ResolvedOther peptic ulcer medication - ResolvedOther peptic ulcer medication - ResolvingEndoscopic hemostasis - ResolvingOther - ResolvedOther - Resolving
Lansoprazole 15 mg31111131113

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Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion

Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion. (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
NoYes
Lansoprazole 15 mg323711

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Presence of Gastric or Duodenal Ulcer

Summary of data on the presence or absence of gastric or duodenal ulcer. (NCT02099708)
Timeframe: From baseline to 12 months

InterventionParticipants (Number)
NoYes
Lansoprazole 15 mg32399

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Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion

Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion. (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
NoYes
Lansoprazole 15 mg32444

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Presence or Absence of Endoscopic Examinations

Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations. (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
NoYes
Lansoprazole 15 mg3098150

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Treatment for Gastric/Duodenal Ulcer or Lesion

Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions. (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
NoYes
Lansoprazole 15 mg011

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Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions

"Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.~Participants could be counted in more than 1 treatment category." (NCT02099708)
Timeframe: From baseline to 12 months

Interventionparticipants (Number)
Takepron Capsule or OD Tablets 15 mgTakepron Capsule or OD Tablet 30 mgRabeprazole tablet 10 mgRabeprazole tablet 20 mgH2 receptor antagonist (oral)Other peptic ulcer medicationEndoscopic hemostasisOther
Lansoprazole 15 mg41111414

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Frequency of Adverse Drug Reactions

Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions. (NCT02099708)
Timeframe: 12 months

Interventionparticipants (Number)
BronchitisColon cancerDepressionCervical radiculopathyAtrial fibrillationCardiac failureMyocardial ischaemiaAbdominal discomfortAbdominal pain upperColitisConstipationDiarrhoeaEnterocolitisNauseaOral mucosal blisteringStomatitisColitis microscopicFaeces softEczemaHyperhidrosisRashGeneralised erythemaOsteoporosisFeeling abnormalThirst
Lansoprazole 15 mg1111111411281111121111212

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Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3

(NCT02128490)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0
Febuxostat IR 40 mg13.5
Febuxostat XR 40 mg35.9
Febuxostat IR 80 mg40.5
Febuxostat XR 80 mg44.7

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Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3

(NCT02128490)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0
Febuxostat IR 40 mg32.4
Febuxostat XR 40 mg53.8
Febuxostat IR 80 mg59.5
Febuxostat XR 80 mg55.3

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Percentage of Participants With at Least One Gout Flare Requiring Treatment

"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare." (NCT02128490)
Timeframe: Baseline to Month 3

Interventionpercentage of participants (Number)
Placebo10.5
Febuxostat IR 40 mg40.5
Febuxostat XR 40 mg23.1
Febuxostat IR 80 mg37.8
Febuxostat XR 80 mg42.1

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Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3

(NCT02139046)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0.3
Febuxostat IR 40 mg15.7
Febuxostat XR 40 mg25.9
Febuxostat IR 80 mg42.6
Febuxostat XR 80 mg50.1

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Percentage of Participants With at Least One Gout Flare Requiring Treatment

"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare." (NCT02139046)
Timeframe: Baseline to Month 3

Interventionpercentage of participants (Number)
Placebo20.7
Febuxostat IR 40 mg21.0
Febuxostat XR 40 mg22.8
Febuxostat IR 80 mg27.2
Febuxostat XR 80 mg26.6

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Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3

(NCT02139046)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0.6
Febuxostat IR 40 mg40.3
Febuxostat XR 40 mg48.2
Febuxostat IR 80 mg57.7
Febuxostat XR 80 mg61.1

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Number of Participants Reporting One or More Adverse Drug Reactions

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionparticipants (Number)
Lansoprazole35

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Number of Participants Reporting One or More Serious Adverse Drug Reactions

Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionparticipants (Number)
Lansoprazole9

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Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect

Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole1.2

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Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect

Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole1.1

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Percentage of Participants With Confirmed Hemostatic Effect

Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole91.6

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Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment

Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. (NCT02151786)
Timeframe: Week 8 after the last dose of study drug (Week 17)

Interventionpercentage of participants (Number)
Lansoprazole7.1

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Percentage of Participants With Observed Hemostatic Effect

Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect. (NCT02151786)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole90.3

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Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment

Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis. (NCT02151786)
Timeframe: Week 8 after the last dose of study drug (Week 17)

Interventionpercentage of participants (Number)
Lansoprazole5.8

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Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)

Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia. (NCT02162758)
Timeframe: Month 12

Interventionpercentage of participants (Number)
Dexlansoprazole 60 mg QD0
Dexlansoprazole 60 mg BID50

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Percentage of Participants With Recurrence of IM With Dysplasia

Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia. (NCT02162758)
Timeframe: Month 12

Interventionpercentage of participants (Number)
Dexlansoprazole 60 mg QD0
Dexlansoprazole 60 mg BID0

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Percentage of Participants With Erosive Esophagitis (EE)

The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference. (NCT02162758)
Timeframe: Baseline up to Month 12

Interventionpercentage of participants (Number)
Dexlansoprazole 60 mg QD0
Dexlansoprazole 60 mg BID0

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Percentage of Participants With Observed Hemostatic Effect

Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect. (NCT02170207)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole96.6

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Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment

Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. (NCT02170207)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole0

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Number of Participants Reporting One or More Adverse Drug Reactions

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. (NCT02170207)
Timeframe: Baseline up to Week 9

Interventionparticipants (Number)
Lansoprazole0

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Percentage of Participants With Confirmed Hemostatic Effect

Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect. (NCT02170207)
Timeframe: Baseline up to Week 9

Interventionpercentage of participants (Number)
Lansoprazole95.6

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Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment

Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis. (NCT02170207)
Timeframe: Week 17 (8 weeks after the last dose of study drug)

Interventionpercentage of participants (Number)
Lansoprazole0

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Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms

The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

,
Interventionparticipants (Number)
Heartburn, NoneHeartburn, MildHeartburn, ModerateHeartburn, SevereHeartburn, Very SevereAcid Regurgitation, NoneAcid Regurgitation, MildAcid Regurgitation, ModerateAcid Regurgitation, SevereAcid Regurgitation, Very SevereDysphagia, NoneDysphagia, MildDysphagia, ModerateDysphagia, SevereDysphagi, Very SevereBelching, NoneBelching, MildBelching, ModerateBelching, SevereBelching, Very SevereEpigastric Pain, NoneEpigastric Pain, MildEpigastric Pain, ModerateEpigastric Pain, SevereEpigastric Pain, Very Severe
Dexlansoprazole 30 mg77922063977617711692261013846121114442930
Dexlansoprazole 60 mg5121310522130071500057172005818000

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Percentage of 24-hour Acid Regurgitation-free Days

Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries. (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Interventionpercentage of days (Median)
Dexlansoprazole 30 mg75.00
Dexlansoprazole 60 mg88.46

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Percentage of 24-hour Heartburn-free Days

Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries. (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Interventionpercentage of days (Median)
Dexlansoprazole 30 mg53.85
Dexlansoprazole 60 mg81.97

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Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries. (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Interventionpercentage of nights (Median)
Dexlansoprazole 30 mg73.08
Dexlansoprazole 60 mg92.73

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Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries. (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Interventionpercentage of nights (Median)
Dexlansoprazole 30 mg59.26
Dexlansoprazole 60 mg83.33

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Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus

Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference. (NCT02351960)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Dexlansoprazole 60 mg77.3

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Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries. (NCT02351960)
Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Interventionpercentage of nights (Median)
Dexlansoprazole 30 mg88.00
Dexlansoprazole 60 mg92.59

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Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants

EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated. (NCT02351960)
Timeframe: Up to Week 8

Interventionpercentage of days (Median)
Dexlansoprazole 60 mg65.45

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Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants

NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded. (NCT02351960)
Timeframe: Up to Week 4

Interventionpercentage of days (Median)
Dexlansoprazole 30 mg26.92

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Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. (NCT02388724)
Timeframe: On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)

InterventionParticipants (Count of Participants)
Vonoprazan 20 mg93
Lansoprazole 30 mg86

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Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase

Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa. (NCT02388724)
Timeframe: 8 weeks

Interventionpercentage of participants (Number)
Vonoprazan 20 mg92.4
Lansoprazole 30 mg91.3

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Number of Participants With Markedly Abnormal Vital Sign Measurements

Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute. (NCT02388724)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)

,
InterventionParticipants (Count of Participants)
Body Temperature (<35.6 °C)Body Temperature (>37.7 °C)Systolic Blood Pressure (<85 mmHg)Diastolic Blood Pressure (>110 mmHg)Pulse (<50 bpm)
Lansoprazole 30 mg30102
Vonoprazan 20 mg102112

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Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings

Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline. (NCT02388724)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)

,
InterventionParticipants (Count of Participants)
Heart Rate (<50 bpm)QT Interval (≥460 msec)QTcF Interval (≥500, or ≥450 with CHG ≥30 msec)
Lansoprazole 30 mg7105
Vonoprazan 20 mg673

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Number of Participants With Markedly Abnormal Clinical Laboratory Findings

Clinical Laboratory Safety tests included Chemistry, Hematology and Urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter. (NCT02388724)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)

,
InterventionParticipants (Count of Participants)
Hemoglobin (<0.8 x LLN g/L)Neutrophils (<0.5 x LLN %)Eosinophils (>2 x ULN %)Lymphocytes (>1.5 x ULN %)ALT (>3 x ULN U/L)AST (>3 x ULN U/L)GGT (>3 x ULN U/L)CPK (>5 x ULN U/L)Total Protein (>1.2 x ULN g/L)BUN (>10.7 mmol/L)Total Cholesterol (>7.72 mmol/L)Triglycerides (>2.5 x ULN mmol/L)Vitamin B12 (<92 pmol/L)
Lansoprazole 30 mg1202213211231
Vonoprazan 20 mg0010004101360

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Change From Baseline in Serum Pepsinogen II

The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline. (NCT02388724)
Timeframe: Baseline and Weeks 2, 4, and 8

,
Interventionug/L (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8
Lansoprazole 30 mg7.88.87.28.0
Vonoprazan 20 mg7.544.940.731.0

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Change From Baseline in Serum Pepsinogen I

The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline. (NCT02388724)
Timeframe: Baseline and Weeks 2, 4, and 8

,
Interventionmicrograms per liter (ug/L) (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8
Lansoprazole 30 mg99.8129.3118.3117.8
Vonoprazan 20 mg97.6456.5421.8326.8

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Change From Baseline in Serum Gastrin

The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline. (NCT02388724)
Timeframe: Baseline and Weeks 2, 4, and 8

,
Interventionpmol/L (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8
Lansoprazole 30 mg3.658.336.814.71
Vonoprazan 20 mg2.7731.4529.6836.53

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Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment

Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa. (NCT02388724)
Timeframe: Week 2 and Week 4

,
Interventionpercentage of participants (Number)
2 Weeks4 Weeks
Lansoprazole 30 mg67.883.5
Vonoprazan 20 mg75.085.3

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Number of Participants With Abnormal Vital Sign Measurements

The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury. (NCT02388737)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

,,
InterventionParticipants (Count of Participants)
Body Temperature (<35.6 °Celsius)Body Temperature (>37.7 °Celsius)Systolic Blood Pressure (<85 mmHg)Diastolic Blood Pressure (<50 mmHg)Diastolic Blood Pressure (>110 mmHg)Pulse (<50 bpm)Pulse (>120 bpm)
Lansoprazole 15 mg12001030
Vonoprazan 10 mg6020111
Vonoprazan 20 mg3102041

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Number of Participants With Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. (NCT02388737)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

InterventionParticipants (Count of Participants)
Vonoprazan 10 mg157
Vonoprazan 20 mg156
Lansoprazole 15 mg158

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Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase

Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: >/=1 mucosal breaks /=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference. (NCT02388737)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Vonoprazan 10 mg27.8
Vonoprazan 20 mg10.0
Lansoprazole 15 mg35.0

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Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase

Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles [LA] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: >/=1 mucosal breaks /=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference. (NCT02388737)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
Vonoprazan 10 mg13.3
Vonoprazan 20 mg12.3
Lansoprazole 15 mg25.5

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Change From Baseline in Serum Gastrin

(NCT02388737)
Timeframe: Baseline and Weeks 4, 12 and 24

,,
Interventionpmol/L (Mean)
BaselineChange at Week 4Change at Week 12Change at Week 24
Lansoprazole 15 mg21.94-11.21-8.76-7.41
Vonoprazan 10 mg20.4210.0914.4517.47
Vonoprazan 20 mg17.9722.7631.9237.60

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Change From Baseline in Serum Pepsinogen I

(NCT02388737)
Timeframe: Baseline and Weeks 4, 12 and 24

,,
Interventionug/L (Mean)
BaselineChange at Week 4Change at Week 12Change at Week 24
Lansoprazole 15 mg303.3-112.3-123.5-103.9
Vonoprazan 10 mg287.140.5-3.15.9
Vonoprazan 20 mg276.3139.889.955.4

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Change From Baseline in Serum Pepsinogen II

(NCT02388737)
Timeframe: Baseline and Weeks 4, 12 and 24

,,
Interventionug/L (Mean)
BaselineChange at Week 4Change at Week 12Change at Week 24
Lansoprazole 15 mg24.6-10.9-10.9-8.7
Vonoprazan 10 mg22.93.8-1.6-0.6
Vonoprazan 20 mg22.116.59.05.8

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Number of Participants With Abnormal Clinical Laboratory Findings

Clinical laboratory safety tests included chemistry, hematology and urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter. (NCT02388737)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

,,
InterventionParticipants (Count of Participants)
Hematology: Red Blood Cells (>1.2xULN)Hematology: White Blood Cells (>1.5xULN)Hematology: Hemoglobin (<0.8xLLN)Hematology: Hematocrit (<0.8xLLN)Hematology: Platelets (<75x10^9/L)Hematology: Neutrophils (<0.5xLLN)Hematology: Eosinophils (>2xULN)Hematology: Lymphocytes (>1.5xULN)Serum Chemistry: ALT (>3xULN)Serum Chemistry: AST (>3xULN)Serum Chemistry: GGT (>3xULN)Serum Chemistry: CK (CPK) (>5xULN)Serum Chemistry: Albumin (<25 g/L)Serum Chemistry: Creatinine (>177 umol/L)Serum Chemistry: BUN (>10.7 mmol/L)Serum Chemistry: Uric Acid (>0.773 mmol/L)Serum Chemistry: Total Cholesterol (>7.72 mmol/L)Serum Chemistry: Triglycerides (>2.5xULN)Serum Chemistry: Glucose (<2.8 mmol/L)Serum Chemistry: Glucose (>19.4 mmol/L)Serum Chemistry: Potassium (<3.0 mmol/L)Serum Chemistry: Sodium (>150 mmol/L)Serum Chemistry: Vitamin B12 (<92 pmol/L)
Lansoprazole 15 mg11110000027311203610103
Vonoprazan 10 mg10100121124400202211011
Vonoprazan 20 mg00111020102200415500000

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Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline. (NCT02388737)
Timeframe: From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)

,,
InterventionParticipants (Count of Participants)
Heart Rate (<50 bpm)Heart Rate (>120 bpm)QT Interval (>=460 msec)QTcF Interval (>= 500, or >= 450 with CHG >= 30)
Lansoprazole 15 mg4086
Vonoprazan 10 mg8098
Vonoprazan 20 mg7153

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AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117

(NCT02625259)
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Interventionnanogram*hour per milliliter (ng*hr/mL) (Geometric Mean)
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)45727.280
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)66015.952
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)71442.968
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)127143.511
Part-3: TAK-117 900 mg (3*300 mg Tablets)63165.064
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg1018.650

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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117

(NCT02625259)
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Interventionng*hr/mL (Geometric Mean)
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)64165.340
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)96293.083
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)81595.634
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)128336.896
Part-3: TAK-117 900 mg (3*300 mg Tablets)85782.122
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg6547.254

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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117

(NCT02625259)
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Interventionhours (Median)
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)2.067
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)3.000
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)3.000
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)6.033
Part-3: TAK-117 900 mg (3*300 mg Tablets)3.000
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg3.517

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Cmax: Maximum Observed Plasma Concentration for TAK-117

(NCT02625259)
Timeframe: Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)4632.992
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)6225.347
Part-2: TAK-117 600 mg Fasted (2*300 mg Tablets)6455.111
Part-2: TAK-117 600 mg Fed (2*300 mg Tablets)7847.591
Part-3: TAK-117 900 mg (3*300 mg Tablets)5859.156
Part-3: TAK-117 900 mg (3*300 mg Tablets) + Lansoprazole 30 mg190.172

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Part 1: Renal Clearance (CLr) of TAK-117

(NCT02625259)
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose

Interventionliter per hour (L/hr) (Mean)
Part-1: TAK-117 900 mg Capsules (9*100 mg Capsules)0.314
Part-1: TAK-117 900 mg Tablets (3*300 mg Tablets)0.311

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Number of Participants in Which H. Pylori Was Eradicated

To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test. (NCT02646332)
Timeframe: sixth week after the end of anti- H. pylori therapy

Interventionparticipants (Number)
(Dexlan+Amox+Clar+Metr)+(Dexlan+Amox)124
Dexlan+Clarith+Amox+Metro121

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Number of Participants With Fundic Gland Polyp

Numbers of participants with fundic gland polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group75
Lansoprazole Group45

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Number of Participants With G-cell Hyperplasia

Numbers of participants with G-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group87
Lansoprazole Group40

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Number of Participants With Atrophy in Greater Curvature of Middle Gastric Body

Numbers of participants with atrophy in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) in Maintenance Phase

Number of participants reporting one or more TEAEs in Maintenance Phase was reported. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. (NCT02679508)
Timeframe: 260 weeks (Baseline, up to the end of Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group126
Lansoprazole Group64

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Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Middle Gastric Body

Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group15
Lansoprazole Group9

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Number of Participants With Hyperplastic Polyp

Numbers of participants with hyperplastic polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group24
Lansoprazole Group6

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Number of Participants With Gastric Polyp

Numbers of participants with gastric polyp for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group82
Lansoprazole Group46

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Number of Participants With Intestinal Metaplasia in Greater Curvature of Antrum

Numbers of participants with intestinal metaplasia in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group6
Lansoprazole Group6

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Number of Participants With Neutrophilic Infiltration in Greater Curvature of Antrum

Numbers of participants with neutrophilic infiltration in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants With Neutrophilic Infiltration in Greater Curvature of Middle Gastric Body

Numbers of participants with neutrophilic infiltration in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group1
Lansoprazole Group0

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Number of Participants With Intestinal Metaplasia in Greater Curvature of Middle Gastric Body

Numbers of participants with intestinal metaplasia in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants With Parietal Cell Protrusion/Hyperplasia

Numbers of participants with parietal cell protrusion/hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group99
Lansoprazole Group45

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Number of Participants With Presence of H.Pylori in Greater Curvature of Antrum

Numbers of participants with presence of H.pylori in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants With Presence of H.Pylori in Greater Curvature of Middle Gastric Body

Numbers of participants with presence of H.pylori in greater curvature of the middle gastric body for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants With Malignant Alteration of Epithelial Cells

Numbers of participants with malignant alteration of epithelial cells for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Time Frame: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group0
Lansoprazole Group0

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Number of Participants With Atrophy in Greater Curvature of Antrum

Numbers of participants with atrophy in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group7
Lansoprazole Group7

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Number of Participants With Multiple White and Flat Elevated Lesions

Numbers of participants with multiple white and flat elevated lesions for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group8
Lansoprazole Group9

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Number of Participants With Inflammation (Mononuclear Infiltration) in Greater Curvature of Antrum

Numbers of participants with inflammation (mononuclear infiltration) in greater curvature of the antrum for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as histological assessment of gastritis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group11
Lansoprazole Group9

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Percentage of Participants With Recurrence of Erosive Esophagitis (EE)

Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades O and A to D) during the Maintenance Phase. The LA classification graded as follows- Grade O: normal mucosa; Grade A: nonconfluent mucosal breaks <5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionPercentage of participants (Number)
Vonoprazan Group3.8
Lansoprazole Group11.3

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Percentage of Participants Who Healed EE at the End of Healing Phase

Percentage of participants who healed EE at the end of healing phase was reported. (NCT02679508)
Timeframe: Up to Week 8

InterventionPercentage of participants (Number)
Vonoprazan Group1.4
Lansoprazole Group0.0

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Number of Participants With Black Spots

Numbers of participants with black spots for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group8
Lansoprazole Group7

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Number of Participants With Cobblestone Mucosa

Numbers of participants with cobblestone mucosa for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for endoscopic findings. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group23
Lansoprazole Group8

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Number of Participants With Enterochromaffin-like-cell Hyperplasia

Numbers of participants with enterochromaffin-like-cell hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group5
Lansoprazole Group4

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Number of Participants With Foveolar Hyperplasia

Numbers of participants with foveolar hyperplasia for Vonoprazan group and Lansoprazole group at Week 268 (Week 260 in Maintenance Phase) were reported as the endpoint for gastric mucosa histopathology. The number analyzed is the number of participants with data available for analysis. (NCT02679508)
Timeframe: Up to Week 268 (Week 260 in Maintenance Phase)

InterventionParticipants (Count of Participants)
Vonoprazan Group15
Lansoprazole Group1

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Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment

The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%). (NCT02873689)
Timeframe: Up to Week 4

Interventionpercentage of days (Median)
Placebo32.67
Dexlansoprazole 30 mg51.72

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Percentage of Days Without Nighttime Heartburn During Treatment

The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%. (NCT02873689)
Timeframe: Up to Week 4

Interventionpercentage of days (Median)
Placebo54.67
Dexlansoprazole 30 mg67.86

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Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6

Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break >5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75% of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. (NCT02873702)
Timeframe: Month 6

Interventionpercentage of participants (Number)
Maintenance Period: Placebo0
Maintenance Period: Dexlansoprazole 30 mg25

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Healing Period: Percentage of Participants With Complete Healing of EE at Week 8

Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 millimeter [mm] that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break greater than [>] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75 percent (%) of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O. (NCT02873702)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Healing Period: Lansoprazole 30 mg85.0
Healing Period: Dexlansoprazole 60 mg82.4

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Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose

(NCT02892409)
Timeframe: Baseline up to Day 15

Interventionpercentage of participants (Number)
Clarithromycin + Amoxicillin + Bismuth + TAK-4380.0
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole6.7

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Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

(NCT02892409)
Timeframe: Baseline up to Day 17

Interventionpercentage of participants (Number)
Clarithromycin + Amoxicillin + Bismuth + TAK-43853.3
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole66.7

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Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose

(NCT02892409)
Timeframe: Baseline up Day 15

,
Interventionpercentage of participants (Number)
Amylase (greater than [>] 2*upper limit of normal)Potassium (>6.0 millimole per liter [mmol/L])
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole6.76.7
Clarithromycin + Amoxicillin + Bismuth + TAK-4380.00.0

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Cmax: Maximum Observed Plasma Concentration for Bismuth

(NCT02892409)
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose

Interventionnanogram per milliliter (ng/mL) (Mean)
Clarithromycin + Amoxicillin + Bismuth + TAK-43828.08
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole30.14

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AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth

(NCT02892409)
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose

Interventionhours nanogram per milliliter (h*ng/mL) (Mean)
Clarithromycin + Amoxicillin + Bismuth + TAK-438103.0
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole111.1

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Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

(NCT02892409)
Timeframe: Baseline up to Day 15

,
Interventionpercentage of participants (Number)
Body temperature (less than [<] 35.6 celsius [C])Body temperature (>37.7 C)Systolic blood pressure(<85 millimeter of mercury)Diastolic blood pressure(<50millimeter of mercury)
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole6.76.76.76.7
Clarithromycin + Amoxicillin + Bismuth + TAK-4380.06.76.76.7

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Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth

(NCT02892409)
Timeframe: Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose

Interventionnanogram (ng) (Mean)
Clarithromycin + Amoxicillin + Bismuth + TAK-438497300
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole537600

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Percentage of Participants Who Discontinue Due to an Adverse Event (AE)

(NCT02892409)
Timeframe: Baseline up to Day 17

Interventionpercentage of participants (Number)
Clarithromycin + Amoxicillin + Bismuth + TAK-4386.7
Clarithromycin + Amoxicillin + Bismuth + Lansoprazole0.0

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Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU

The gastrointestinal symptoms included epigastric pain [postprandial, fasting, nocturnal], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU. (NCT03050307)
Timeframe: Week 2 up to Week 8

,
Interventionpercentage of participants (Number)
Epigastric Pain (Postprandial)Epigastric Pain (Fasting/Nocturnal)Abdominal BloatingNausea/VomitingHeartburnLack of Appetite
Lansoprazole 30 mg80.080.565.2100.085.790.0
TAK-438 20 mg78.985.081.3100.095.877.8

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Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment

HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP. (NCT03050307)
Timeframe: 4 weeks post treatment (up to approximately 12 weeks)

Interventionpercentage of participants (Number)
TAK-438 20 mg88.0
Lansoprazole 30 mg80.8

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Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4

Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically. (NCT03050307)
Timeframe: Week 4

Interventionpercentage of participants (Number)
TAK-438 20 mg76.1
Lansoprazole 30 mg82.1

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Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8

Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically. (NCT03050307)
Timeframe: Week 4 or 8

Interventionpercentage of participants (Number)
TAK-438 20 mg91.1
Lansoprazole 30 mg94.7

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Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4

Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically. (NCT03050359)
Timeframe: Week 4

Interventionpercentage of participants (Number)
TAK-438 20 mg89.2
Lansoprazole 30 mg88.4

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Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6

The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. (NCT03050359)
Timeframe: Week 2 up to Week 6

,
Interventionpercentage of participants (Number)
Epigastric Pain (Postprandial)Epigastric Pain (Fasting/Nocturnal)Abdominal BloatingNausea/VomitingHeartburnLack of Appetite
Lansoprazole 30 mg91.890.187.394.495.5100.0
TAK-438 20 mg87.791.783.385.2100.090.9

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Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment

HP infection status was determined by ^13C Urea Breath Test (^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. (NCT03050359)
Timeframe: 4 weeks post treatment (Up to 10 weeks)

Interventionpercentage of participants (Number)
TAK-438 20 mg91.5
Lansoprazole 30 mg86.8

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Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers

Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically. (NCT03050359)
Timeframe: Week 4 or Week 6

Interventionpercentage of participants (Number)
TAK-438 20 mg96.9
Lansoprazole 30 mg96.5

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Sex Hormone Binding Globulin (SHBG)

Change in Serum Levels of SHBG (sex hormone binding globuline) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionnmol/L (Mean)
Tirosint Capsules0.884

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Low Density Lipoprotein (LDL)-Cholesterol

Change in low density lipoprotein (LDL)-cholesterol levels from baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmmol/L (Mean)
Tirosint Capsules-0.210

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High Density Lipoprotein (HDL)-Cholesterol

Change in High Density Lipoprotein (HDL)-cholesterol levels from baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmmol/L (Mean)
Tirosint Capsules-0.029

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Free Triiodothyronine (FT3)

Change in Serum Levels of FT3 (free triiodothyronine) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionpmol/L (Mean)
Tirosint Capsules0.263

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Free Thyroxine (FT4)

Change in Serum Levels of FT4 (free thyroxine) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionpmol/L (Mean)
Tirosint Capsules0.593

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Very Low Density Lipoprotein (VLDL)-Cholesterol

Change in Very Low Density Lipoprotein (VLDL)-cholesterol levels from baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmmol/L (Mean)
Tirosint Capsules0.049

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Creatine Phosphokinase (CPK)

Change in Serum Levels of creatine phosphokinase (CPK) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

InterventionU/L (Mean)
Tirosint Capsules-35.073

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Thyroid Stimulating Hormone (TSH)

Change in Serum Levels of TSH (Thyroid Stimulating Hormone) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

InterventionmIU/L (Mean)
Tirosint Capsules-0.676

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Angiotensin Converting Enzyme (ACE)

Change in Serum Levels of ACE (angiotensin converting enzyme) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

InterventionU/L (Mean)
Tirosint Capsules-0.395

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Cholesterol, Total

Change in total cholesterol levels from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmmol/L (Mean)
Tirosint Capsules-0.198

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Triglycerides

Change in triglycerides levels from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmmol/L (Mean)
Tirosint Capsules0.075

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Total Triiodothyronine (TT3)

Change in Serum Levels of TT3 (total triiodothyronine) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionnmol/L (Mean)
Tirosint Capsules0.098

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Total Thyroxine (TT4)

Change in Serum Levels of TT4 (total thyroxine) from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionnmol/L (Mean)
Tirosint Capsules2.558

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Ferritin

Change in Serum Levels of ferritin from Baseline (NCT03094416)
Timeframe: baseline and 12 weeks

Interventionmcg/L (Mean)
Tirosint Capsules-6.442

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AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole

(NCT03131895)
Timeframe: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose

Interventionnanogram*hour per milliliter(ng*hour/mL) (Mean)
Dexlansoprazole 30 mg TOB2416.3
Dexlansoprazole 30 mg TPC2327.6
Dexlansoprazole 60 mg TOB5715.5
Dexlansoprazole 60 mg TPC5684.7

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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole

(NCT03131895)
Timeframe: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose

Interventionng*hour/mL (Mean)
Dexlansoprazole 30 mg TOB2579.6
Dexlansoprazole 30 mg TPC2420.6
Dexlansoprazole 60 mg TOB5746.2
Dexlansoprazole 60 mg TPC5630.4

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Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

(NCT03131895)
Timeframe: Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose

Interventionnanogram/milliliter (ng/mL) (Mean)
Dexlansoprazole 30 mg TOB515.7
Dexlansoprazole 30 mg TPC519.5
Dexlansoprazole 60 mg TOB1027.0
Dexlansoprazole 60 mg TPC978.6

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AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole

(NCT03316976)
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Interventionhour*nanogram per milliliter (h*ng/mL) (Geometric Mean)
Group 1: Dexlansoprazole 30 mg3660
Group 2: Dexlansoprazole 60 mg10198

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AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole

(NCT03316976)
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Interventionh*ng/mL (Geometric Mean)
Group 1: Dexlansoprazole 30 mg3701
Group 2: Dexlansoprazole 60 mg10340

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Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

(NCT03316976)
Timeframe: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Interventionnanogram per milliliter (ng/mL) (Geometric Mean)
Group 1: Dexlansoprazole 30 mg732
Group 2: Dexlansoprazole 60 mg1756

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AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole

(NCT03801148)
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Interventionng*hour/mL (Geometric Mean)
Part 1: Dexlansoprazole 30 mg TOB2926
Part 1: Dexlansoprazole 30 mg TPC2884
Part 2: Dexlansoprazole 60 mg TOB6733
Part 2: Dexlansoprazole 60 mg TPC6217

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AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole

(NCT03801148)
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Interventionng*hour/mL (Geometric Mean)
Part 1: Dexlansoprazole 30 mg TOB2927
Part 1: Dexlansoprazole 30 mg TPC2885
Part 2: Dexlansoprazole 60 mg TOB6734
Part 2: Dexlansoprazole 60 mg TPC6220

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AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole

(NCT03801148)
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Interventionnanogram*hour per milliliter(ng*hour/mL) (Geometric Mean)
Part 1: Dexlansoprazole 30 mg TOB2881
Part 1: Dexlansoprazole 30 mg TPC2756
Part 2: Dexlansoprazole 60 mg TOB6608
Part 2: Dexlansoprazole 60 mg TPC6278

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Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole

(NCT03801148)
Timeframe: Day 1 pre-dose and at multiple time points (up to 24 hours) post dose

Interventionnanogram/milliliter (ng/mL) (Geometric Mean)
Part 1: Dexlansoprazole 30 mg TOB610.1
Part 1: Dexlansoprazole 30 mg TPC622.5
Part 2: Dexlansoprazole 60 mg TOB1381
Part 2: Dexlansoprazole 60 mg TPC1302

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Maintenance Phase: Percentage of 24-hour Heartburn-free Days

A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase. (NCT04124926)
Timeframe: Day 1 to Week 24

Interventionpercentage of days (Mean)
Maintenance Phase: Vonoprazan 10 mg80.9
Maintenance Phase: Vonoprazan 20 mg80.6
Maintenance Phase: Lansoprazole 15 mg78.6

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Maintenance Phase: Percentage of Participants Who Maintained Complete Healing of EE at Week 24

A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. (NCT04124926)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Maintenance Phase: Vonoprazan 10 mg79.2
Maintenance Phase: Vonoprazan 20 mg80.7
Maintenance Phase: Lansoprazole 15 mg72.0

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Maintenance Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Maintained Complete Healing of EE at Week 24

"A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.~LA Classification of Esophagitis Grading Scale:~Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference.~Grade D: One or more mucosal breaks, which involves at least 75% of the circumference." (NCT04124926)
Timeframe: Week 24

Interventionpercentage of participants (Number)
Maintenance Phase: Vonoprazan 10 mg74.7
Maintenance Phase: Vonoprazan 20 mg77.2
Maintenance Phase: Lansoprazole 15 mg61.5

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Healing Phase: Percentage of Participants With Onset of Sustained Resolution of Heartburn by Day 3

Sustained resolution was defined as at least 7 consecutive days with no daytime or night time heartburn as assessed by the daily diary. A participant was considered to have sustained resolution of heartburn by Day 3 if the first day of the 7 consecutive days without symptoms was on Days 1, 2, or 3. (NCT04124926)
Timeframe: Day 1 to maximum of Day 10 (inclusive of 7 day heartburn assessment)

Interventionpercentage of participants (Number)
Healing Phase: Vonoprazan 20 mg34.4
Healing Phase: Lansoprazole 30 mg32.2

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Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE by Week 8

"A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.~LA Classification of Esophagitis Grading Scale:~Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference.~Grade D: One or more mucosal breaks, which involves at least 75% of the circumference." (NCT04124926)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Healing Phase: Vonoprazan 20 mg91.7
Healing Phase: Lansoprazole 30 mg72.0

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Healing Phase: Percentage of Participants With Baseline LA Classification Grades C or D Who Had Complete Healing of EE at Week 2

"A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.~LA Classification of Esophagitis Grading Scale:~Grade C: One or more mucosal breaks that are continuous between the tops of 2 or more mucosal folds, which involves less than 75% of the circumference.~Grade D: One or more mucosal breaks, which involves at least 75% of the circumference." (NCT04124926)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Healing Phase: Vonoprazan 20 mg70.2
Healing Phase: Lansoprazole 30 mg52.6

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Healing Phase: Percentage of Participants Who Had Complete Healing of EE by Week 8

A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. (NCT04124926)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Healing Phase: Vonoprazan 20 mg92.9
Healing Phase: Lansoprazole 30 mg84.6

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Healing Phase: Percentage of Participants Who Had Complete Healing of EE at Week 2

A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy. (NCT04124926)
Timeframe: Week 2

Interventionpercentage of participants (Number)
Healing Phase: Vonoprazan 20 mg74.3
Healing Phase: Lansoprazole 30 mg68.2

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Healing Phase: Percentage of 24-hour Heartburn-free Days

A 24-hour heartburn-free day was defined as a day having no heartburn among all diary entries for that day. The percentage of 24-hour heartburn-free days was calculated using all days with at least 1 evening or morning diary entry during the treatment period of this phase. (NCT04124926)
Timeframe: Day 1 to Week 8

Interventionpercentage of days (Mean)
Healing Phase: Vonoprazan 20 mg66.8
Healing Phase: Lansoprazole 30 mg64.1

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Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline

H pylori eradication was determined by the ^13C-UBT test. (NCT04167670)
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Interventionpercentage of participants (Number)
Vonoprazan Dual Therapy78.5
Vonoprazan Triple Therapy84.7
Lansoprazole Triple Therapy78.8

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Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline

H pylori eradication was determined by the ^13C-UBT test. (NCT04167670)
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Interventionpercentage of participants (Number)
Vonoprazan Dual Therapy69.6
Vonoprazan Triple Therapy65.8
Lansoprazole Triple Therapy31.9

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Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication

H pylori eradication was determined by the ^13C-UBT test. (NCT04167670)
Timeframe: Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)

Interventionpercentage of participants (Number)
Vonoprazan Dual Therapy77.2
Vonoprazan Triple Therapy80.8
Lansoprazole Triple Therapy68.5

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Area Under the Concentration-Time Curve From Time 0 to the 24-Hour Time Point (AUC0-24)

Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionng*hr/mL (Mean)
Vonoprazan200.6
Lansoprazole2677

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Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) at Steady State (ss)

Calculated using the Linear Trapezoidal with Linear Interpolation Method. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionng*hr/mL (Mean)
Vonoprazan261.4
Lansoprazole3246

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Mean Gastric pH Over a 24-hour Monitoring Period Following Study Drug Administration (pH0-24)

The average gastric pH was a measure of the immediate effect on gastric pH and the duration of effect on gastric pH. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second. The pH scale ranges from 0 to 14 with values below 7 being more acidic and values above 7 being more basic. Normal gastric pH is between 1.5 and 3.5. (NCT04729101)
Timeframe: Day 1 and Day 7 of each treatment period

,
InterventionpH (Mean)
Day 1Day 7
Lansoprazole2.8483.783
Vonoprazan4.6065.903

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Gastric pH >4 Holding Time Ratio (HTR): Percentage of Time Gastric pH Was Above 4 Over a 24-hour Monitoring Period Following Study Drug Administration

Calculated as: Time pH >4*100/total actual monitoring period time. Gastric pH was measured continuously over a 24-hour period on Days 1 and 7 of Periods 1 and 2, using a pH and pressure sensitive probe and ambulatory pH recording system. A pH recording was taken every second. (NCT04729101)
Timeframe: Day 1 and Day 7 of each treatment period

,
Interventionpercentage of time (Mean)
Day 1Day 7
Lansoprazole22.6142.32
Vonoprazan62.4087.81

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Tmax at Steady State (Tmax,ss)

Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax,ss. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionhr (Median)
Vonoprazan2.005
Lansoprazole1.510

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Time to Reach Cmax (Tmax)

Taken from the clinical database as the difference in the time of administration and the time of the blood draw which was associated with the Cmax. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionhr (Median)
Vonoprazan2.005
Lansoprazole1.499

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Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)

Calculated as the area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) + (Clast/Kel) where Clast is the last observed/measured concentration and Kel is the apparent first-order terminal elimination rate constant. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionng*hr/mL (Mean)
Vonoprazan229.5
Lansoprazole2679

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Cmax at Steady State (Cmax,ss)

Cmax,ss was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 7: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionng/mL (Mean)
Vonoprazan27.39
Lansoprazole1164

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Maximum Observed Plasma Concentration (Cmax)

Cmax was taken directly from bioanalytical data. The analyses of vonoprazan and lansoprazole in plasma samples was performed using validated liquid chromatography-mass spectrometry/mass spectrometry methods. (NCT04729101)
Timeframe: Day 1: predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 9, 10, 12, 13, 16, and 24 hours postdose

Interventionng/mL (Mean)
Vonoprazan21.79
Lansoprazole1110

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Percentage of Heartburn-Free 24-hour Days

Heartburn-free in a 24-hour day was a day where patient reported having no burning feeling or pain behind breast or in center of upper stomach for both morning and evening. Percentage of heartburn-free 24-hour days based on eDiary(Reflux Symptom Questionnaire electronic Diary: RESQ-eDiary) was evaluated. Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with four dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks Lansoprazole treatment in open-label. Modified RESQ-eDiary was validated self-reported questionnaire electronic symptom diary. mRESQ-eD has 3 domains [i.e. Heartburn (min-max: 0-10), Other GERD signs/symptoms (min-max:0-15) and Regurgitations/Reflux (min-max: 0-8)]. Endoscopy followed by lansoprazole administration and symptom evaluation using PRO QOLRAD (Heartburn version) and patient diaries assessed acid control achieved with X842 at 4 weeks. (NCT05055128)
Timeframe: Weeks 1 and 8

,,,,
InterventionPercentage of days (Mean)
Week 1Week 8
Lansoprazole19.159.2
X842 100 mg BID26.172.2
X842 25 mg BID27.082.4
X842 50 mg BID25.173.8
X842 75 mg BID29.278.6

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Number of Patients With Esophageal Mucosa Healing

The healing of erosive esophagitis due to gastro-esophageal reflux disease (GERD) was assessed. It supported the dose selection X842,through the assessment of healing of erosive esophagitis due to GERD based on endoscopic assessment after 4 weeks of treatment. The dose that would lead to having 85% of the patients have esophageal mucosa healing after 4 weeks of treatment. Following the endoscopic evaluation, all patients received subsequent 4 weeks of open-label treatment with lansoprazole. Repeated symptom evaluation was assessed during this period to detect the symptom pattern. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation was assessed using the validated patient-reported outcome (PRO) QOLRAD (Heartburn version) and patient diaries (RESQ-eDiary). (NCT05055128)
Timeframe: Week 4

InterventionParticipants (Count of Participants)
X842 25 mg BID28
X842 50 mg BID28
X842 75 mg BID32
X842 100 mg BID18
Lansoprazole20

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Change From Baseline in Quality of Life in Reflux and Dyspepsia (QOLRAD) Score

Reflux-related symptom pattern was evaluated during initial 4 weeks of treatment with 4 dose levels of X842 and with Lansoprazole, and symptom pattern during subsequent additional 4 weeks of open-label treatment with Lansoprazole. Heartburn version of QOLRAD is a disease-specific instrument containing 25 questions addressing concerns associated with gastrointestinal symptoms. Questions were rated on a seven-grade (1-7) Likert scale, where a score of 1 represented low quality of life, and as score increased, the patient's condition was considered better. Questions were categorized into 5 domains: emotional distress, sleep disturbance, vitality, food/drink problems, and physical/social functioning. The score in each domain was calculated as the mean of all items in that domain. The score ranges from 1 to 175, higher scores mean a better outcome. After endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD and patient diaries. (NCT05055128)
Timeframe: Baseline, Weeks 1, and 8

,,,,
InterventionScores on scale (Mean)
Week 1: Emotional Distress ScoreWeek 8: Emotional Distress ScoreWeek 1: Food/Drink Problems ScoreWeek 8: Food/Drink Problems ScoreWeek 1: Physical/Social Functioning ScoreWeek 8: Physical/Social Functioning ScoreWeek 1: Sleep Disturbance ScoreWeek 8: Sleep Disturbance ScoreWeek 1:Vitality ScoreWeek 8: Vitality Score
Lansoprazole1.342.191.402.560.971.711.542.371.212.19
X842 100 mg BID1.542.001.652.281.191.601.491.911.502.21
X842 25 mg BID1.692.761.843.081.262.061.602.781.552.84
X842 50 mg BID1.552.511.622.971.322.261.452.481.512.79
X842 75 mg BID1.141.841.322.341.021.571.081.891.422.25

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Investigator Assessment of Symptoms by Frequency and Severity

Investigator assessed severity and frequency of patients' heartburn, regurgitation, and dysphagia in 7 days. Assessment included both severity grade (for severity, items were coded: none, mild, moderate, severe where none represented no complaints, severe represented incapacitating symptoms) and frequency (for frequency, a 7-graded Likert scale was used, ranging from none to all of time) of symptoms. Symptoms were scored as follows: none (no complaints), mild (aware of symptom, but easily tolerated), moderate (discomforting symptom, sufficient to cause interference with normal daily activities and/or sleep), severe (incapacitating symptom, with inability to perform normal daily activities and/or sleep). Following endoscopic evaluation, patients received lansoprazole and underwent symptom evaluation using validated PRO QOLRAD (Heartburn version) and patient diaries.Here, for frequency- All of the time and None of the time, and for symptoms- none and severe data has been presented. (NCT05055128)
Timeframe: Weeks 1 and 8

,,,,
InterventionParticipants (Count of Participants)
Week 1 (Dysphagia): Frequency- All of the timeWeek 1 (Dysphagia): Frequency- None of the timeWeek 8 (Dysphagia): Frequency- All of the timeWeek 8 (Dysphagia): Frequency- None of the timeWeek 1 (Heartburn): Frequency- All of the timeWeek 1 (Heartburn): Frequency- None of the timeWeek 8 (Heartburn): Frequency- All of the timeWeek 8 (Heartburn): Frequency- None of the timeWeek 1 (Regurgitation/Reflux): Frequency- All of the timeWeek 1 (Regurgitation/Reflux): Frequency- None of the timeWeek 8 (Regurgitation/Reflux): Frequency- All of the timeWeek 8 (Regurgitation/Reflux): Frequency- None of the timeWeek 1 (Dysphagia): Symptom- NoneWeek 1 (Dysphagia): Symptom- SevereWeek 8 (Dysphagia): Symptom- NoneWeek 8 (Dysphagia): Symptom- SevereWeek 1 (Heartburn): Symptom- NoneWeek 1 (Heartburn): Symptom- SevereWeek 8 (Heartburn): Symptom- NoneWeek 8 (Heartburn): Symptom- SevereWeek 1 (Regurgitation/Reflux): Symptom- NoneWeek 1 (Regurgitation/Reflux): Symptom- SevereWeek 8 (Regurgitation/Reflux): Symptom- NoneWeek 8 (Regurgitation/Reflux): Symptom- Severe
Lansoprazole01104031036030391214101338032411
X842 100 mg BID11313434033141321523505233054330
X842 25 mg BID01404241038110411414201538113410
X842 50 mg BID21003700037020361223700137033360
X842 75 mg BID01304334043240411324304444165410

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Number of Patients With Adverse Events (AEs)

The safety and tolerability of the four dose levels of X842 and Lansoprazole were evaluated, where Lansoprazole served as the active comparator. Here TEAE- Treatment-emergent adverse event, ADR- Adverse drug reaction, SAE- Serious adverse event, and AESI- Adverse events of special interest. (NCT05055128)
Timeframe: From Screening (Day -7 to Day 0) until Week 8

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InterventionParticipants (Count of Participants)
Any AEAny TEAEAny severe TEAEAny treatment related TEAE (ADR)Any TEAE leading to study discontinuationAny SAEAny Serious TEAEAny treatment emergent AESI
Lansoprazole1010020000
X842 100 mg BID1111021000
X842 25 mg BID1514141110
X842 50 mg BID1010020000
X842 75 mg BID1212000110

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Percentage at Most-mild Heartburn 24-hour Days

Heartburn with at most mild symptoms in a 24-hour day was defined as a day where the patient reported having either no symptoms, very mild symptoms, or mild burning feeling or pain behind the breast or in the center of the upper stomach (score between 0-2) for both morning and evening. Heartburn assessed the severity as per the following scores (0=Did not have, 1=Very mild, 2=Mild, 3=Moderate, 4=Moderately severe, 5=Severe). Here higher scores represent the worst outcome, whereas lower scores represent the better outcome. After endoscopic evaluation, patients received lansoprazole, and symptom evaluation was conducted to detect patterns. Endoscopy evaluation at 4 weeks was based on the level and duration of acid control achieved with X842. Symptom evaluation involved the use of validated PRO QOLRAD (Heartburn version) and patient diaries. (NCT05055128)
Timeframe: Weeks 1 and 8

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InterventionPercentage of days (Mean)
Week 1Week 8
Lansoprazole63.192.2
X842 100 mg BID69.797.1
X842 25 mg BID75.398.5
X842 50 mg BID67.996.5
X842 75 mg BID79.495.8

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