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ranitidine bismuth citrate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

ranitidine bismuth citrate: Pylorid & Tritec are tradenames [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID3033887
MeSH IDM0198352

Synonyms (20)

Synonym
gr-122311-x
ranitidine bismutrex
tritec
pylorid
ranitidine bismuth citrate (usan)
D05699
tritec (tn)
128345-62-0
elicodil
azamplus
helirad
n-(2-((5-((dimethylamino)methyl)furfuryl)thio)ethyl)-n'-methyl-2-nitro-1,1-ethenediamine, compound with bismuth(3(+)) citrate (1:1)
pylorisan
ranitidine bismuth citrate
unii-7aj51i17kg
Q3930120
ranitidine (bismuth citrate)
CS-0014408
HY-B0693A
ranitidine bismuth citrate (mart.)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Adverse reactions to these agents are mild, transient and infrequent, and reports of serious adverse reactions are rare."( Review article: safety of bismuth in the treatment of gastrointestinal diseases.
Dixon, JS; Drake, FM; Tillman, LA; Wood, JR, 1996
)
0.29
" No adverse events were specifically attributed to ranitidine bismuth citrate."( The safety and efficacy of ranitidine bismuth citrate in combination with antibiotics for the eradication of Helicobacter pylori.
Bardhan, KD; Buckley, MJ; De Koster, EH; Duggan, AE; Gilvarry, J; Gummett, PA; Logan, RP; O'Morain, CA; Pounder, RE; Rauws, EA; Schaufelberger, HD; Wyeth, JW, 1996
)
0.29
" Twenty-four patients experienced side-effects, but in only seven cases was treatment discontinued due to adverse events."( Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate.
Bazzoli, F; Cannizzaro, O; D'Angelo, A; Ederle, A; Fossi, S; Gerace, G; Iaquinto, G; Olivieri, A; Pozzato, P; Reina, G; Ricciardiello, L; Roda, E; Scarpulla, G; Spadaccini, A; Tosatto, R; Zagari, M, 1998
)
0.3
" Three novel RBC-based triple therapies proved to be safe and well tolerated, with discontinuations due to side-effects occurring in less than 5% of cases."( Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate.
Bazzoli, F; Cannizzaro, O; D'Angelo, A; Ederle, A; Fossi, S; Gerace, G; Iaquinto, G; Olivieri, A; Pozzato, P; Reina, G; Ricciardiello, L; Roda, E; Scarpulla, G; Spadaccini, A; Tosatto, R; Zagari, M, 1998
)
0.3

Pharmacokinetics

ExcerptReferenceRelevance
" After the last dose the geometric mean for Cmax for 500 mg bid of GR122311X was 5 ng."( Comparative pharmacokinetics of bismuth from ranitidine bismuth citrate (GR122311X), a novel anti-ulcerant and tripotassium dicitrato bismuthate (TDB).
Frazer, NM; Keene, ON; Lacey, LF; Smith, JT, 1994
)
0.29

Compound-Compound Interactions

ExcerptReferenceRelevance
"To test eradication and adverse events of ranitidine bismuth citrate (RBC) when given with metronidazole and either oxytetracycline or spiramycin."( Spiramycin is comparable to oxytetracycline in eradicating H. pylori when given with ranitidine bismuth citrate and metronidazole.
Bang, CJ; Berstad, A; Coll, P; Hatlebakk, JG; Hausken, T; Nysaeter, G; Olafsson, S; Olafsson, T; Tefera, S, 1999
)
0.3

Bioavailability

ExcerptReferenceRelevance
" This, in part, reflects the low systemic bioavailability of bismuth from these medicines: less than 1% of the bismuth dose administered is absorbed."( Review article: safety of bismuth in the treatment of gastrointestinal diseases.
Dixon, JS; Drake, FM; Tillman, LA; Wood, JR, 1996
)
0.29

Dosage Studied

Bismuth particles were found to be interposed between epithelial cells in the antral mucosa of three of eight patients who were dosed with ranitidine bismuth citrate.

ExcerptRelevanceReference
" Thirty minutes after dosing each subject was given 375 ml of 99mTc-DTPA (diethylene triaminepentaacetic acid) labelled Clinifeed-ISO."( Ranitidine bismuth citrate and ranitidine do not affect gastric emptying of a radio-labelled liquid meal.
Bedding, AW; Farr, SJ; Forster, ER; Parikh, R; Smith, JT; Sweetland, J, 1994
)
0.29
" Twenty four men with duodenal ulcers were studied before and on the 8th day of dosing with either ranitidine bismuth citrate 800 mg twice daily or ranitidine 300 mg twice daily (double blind, randomised, parallel groups)."( Effect of ranitidine bismuth citrate on postprandial plasma gastrin and pepsinogens.
Fraser, AG; Hudson, M; Lam, WM; Luk, YW; Pounder, RE; Samloff, IM; Sawyerr, AM; Sercombe, J, 1993
)
0.29
"To determine whether bismuth penetrates the gastric mucosa after dosing with ranitidine bismuth citrate."( Gastric persorption of bismuth from ranitidine bismuth citrate.
Fraser, AG; Lewin, JF; Pounder, RE, 1995
)
0.29
"Bismuth particles were found to be interposed between epithelial cells in the antral mucosa of three of eight patients who were dosed with ranitidine bismuth citrate."( Gastric persorption of bismuth from ranitidine bismuth citrate.
Fraser, AG; Lewin, JF; Pounder, RE, 1995
)
0.29
"Penetration of bismuth particles into the gastric mucosa may occur after oral dosing with ranitidine bismuth citrate."( Gastric persorption of bismuth from ranitidine bismuth citrate.
Fraser, AG; Lewin, JF; Pounder, RE, 1995
)
0.29
"Disposition pharmacokinetics of bismuth following oral dosing of ranitidine bismuth citrate are complicated and variable."( Modeling of trough plasma bismuth concentrations.
Bennett, JE; Lacey, LF; Wakefield, JC, 1997
)
0.3
" Such a synergistic effect probably explains the increased efficacy of RBC-clarithromycin dual therapies compared with clarithromycin dosed with acid-suppressive agents such as H2-receptor antagonists or proton-pump inhibitors."( New options in Helicobacter pylori eradication: efficacy, resistance and synergy.
Pipkin, GA; Williamson, R; Wood, JR, 1998
)
0.3
" After dosing with bismuth alone or in association with ranitidine hydrochloride, bismuth was detected in several organs and deposition was not influenced by gastric pH."( Distribution of bismuth in the rat after oral dosing with ranitidine bismuth citrate and bismuth subcitrate.
Canena, J; Leitão, J; Pinheiro, T; Pinto, AS; Quina, MG; Reis, J; Santos, AM, 1998
)
0.3
" dosing schedule: RBC 400 mg plus clarithromycin 250 mg and tinidazole 500 mg (RBCCT): RBC 400 mg plus clarithromycin 500 mg and amoxycillin 1 g (RBCCA); RBC 400 mg plus tinidazole 500 mg and amoxycillin 1 g (RBCTA)."( Efficacy and safety of three 7-day Helicobacter pylori eradication regimens containing ranitidine bismuth citrate.
Bazzoli, F; Cannizzaro, O; D'Angelo, A; Ederle, A; Fossi, S; Gerace, G; Iaquinto, G; Olivieri, A; Pozzato, P; Reina, G; Ricciardiello, L; Roda, E; Scarpulla, G; Spadaccini, A; Tosatto, R; Zagari, M, 1998
)
0.3
"In order to improve the efficacy and simplicity of the FDA-approved regimen of ranitidine bismuth citrate (RBC) and clarithromycin dual therapy, we added an inexpensive antibiotic (metronidazole), changed the dosage scheme to twice daily dosing, and decreased the duration of therapy to 1 week."( Efficacy of a 1-week regimen of ranitidine bismuth citrate in combination with metronidazole and clarithromycin for Helicobacter pylori eradication.
Cave, DR; Hoffman, JS; Katz, LM, 1999
)
0.3
" Pre-treatment with a proton pump inhibitor, higher doses or more frequent dosing may be necessary to increase the cure rate of short duration regimens."( Comparison of two 3-day Helicobacter pylori eradication regimens with a standard 1-week regimen.
Cross, R; Grimley, CE; Illing, RC; Lismore, JR; Loft, DE; Nwokolo, CU; O'sullivan, M; Penny, A; Shebani, M, 1999
)
0.3
" pylori treatment: effectiveness (>80%), simplicity (twice-daily dosing and excellent compliance) and safety (low incidence of adverse effects)."( First-line triple therapy with levofloxacin for Helicobacter pylori eradication.
Fernández-Bermejo, M; Gisbert, JP; González-García, G; Mateos-Rodríguez, JM; Molina-Infante, J; Pérez-Gallardo, B; Prieto-Bermejo, AB; Robledo-Andrés, P, 2007
)
0.34
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (165)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's77 (46.67)18.2507
2000's82 (49.70)29.6817
2010's4 (2.42)24.3611
2020's2 (1.21)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials101 (59.06%)5.53%
Reviews27 (15.79%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other43 (25.15%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (51)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Randomized,2-way Crossover, Bioequivalence Study of Ranitidine 300 mg Tablets Zantac 300 mg Tablets Administered as 1 x 300 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT01131702]Phase 124 participants (Actual)Interventional2003-01-31Completed
Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration [NCT04397445]Phase 118 participants (Actual)Interventional2020-06-08Completed
The Study of the Diagnosis of Eustachian Tube Dysfunction (ETD): Identifying the Relationship of Ear Fullness to Laryngopharyngeal Reflux (LPR) [NCT02123498]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to IRB not approved)
The Effect of Concomitant Cimetidine p.o. 400 mg t.i.d. and p.o. Ranitidine 300 mg Once Daily on Single Dose Pharmacokinetics of Tiotropium (14.4 µg) Given Intravenously Over 15 Minutes in Healthy Male and Female Subjects of 50-65 Years (Randomized, Open [NCT02172417]Phase 118 participants (Actual)Interventional2000-07-31Completed
A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial [NCT02197143]Phase 4286 participants (Actual)Interventional2013-03-31Completed
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 I Open-label, Randomised, Single Dose, Three-way Crossover Relative Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) Formula [NCT02195804]Phase 142 participants (Actual)Interventional2009-05-31Completed
Bioavailability of BIBR 953 ZW After Single Oral Doses of 12.5, 50 or 200 mg BIBR 1048 MS Film-coated Tablet Over 2 Days With and Without Coadministration of Ranitidine to Healthy Subjects. Three Groups, 2-way Crossover, Randomised, Open Trial. [NCT02170792]Phase 130 participants (Actual)Interventional2001-02-28Completed
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects [NCT01209455]24 participants (Anticipated)Interventional2011-01-31Recruiting
An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness [NCT00668317]Phase 35 participants (Actual)Interventional2006-09-30Terminated(stopped due to Primary care physicians began prescribing antacid therapy for chronic cough)
A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued [NCT00633672]Phase 3400 participants (Anticipated)Interventional2001-02-28Completed
Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block [NCT02441673]Phase 2130 participants (Anticipated)Interventional2018-10-12Not yet recruiting
A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, 8 Week Comparative Efficacy and Safety Study of Esomeprazole 20 mg Every Day (qd) Versus Ranitidine 150 mg Twice a Day (Bid) in Patients With an NSAID-associated Gastric Ulcer When Dai [NCT00401752]Phase 3397 participants (Actual)Interventional2006-03-31Completed
Extending Acute Stroke Trials to the Aerial Inter-hospital Transfer Setting (AIRDOC) [NCT00585351]100 participants (Actual)Interventional2007-01-31Completed
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor [NCT05298683]Phase 2108 participants (Anticipated)Interventional2022-05-31Not yet recruiting
A Randomized Double-Blind Parallel Study of Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD) [NCT00839306]Phase 3240 participants (Actual)Interventional2008-08-31Completed
Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD) [NCT00838526]Phase 3240 participants (Actual)Interventional2008-08-31Completed
An Open-Label, 3-Period, Fixed Sequence Study to Evaluate the Effect of an H2 Antagonist and a Proton Pump Inhibitor on the Single Dose Pharmacokinetics of LOXO-292 in Healthy Adult Subjects [NCT05338502]Phase 120 participants (Actual)Interventional2019-07-08Completed
[NCT02733640]42 participants (Actual)Interventional2012-10-31Completed
Evaluation of the Influence of Statins and Proton Pump Inhibitors on Clopidogrel Antiplatelet Effects [NCT00930670]Phase 4320 participants (Actual)Interventional2009-06-30Completed
In Infants With Symptoms of Tracheomalacia or Laryngomalacia, Does Acid-Blocking Medication Improve Respiratory Symptoms? A Randomized, Controlled Trial [NCT02700087]0 participants (Actual)Interventional2016-02-29Withdrawn
Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis [NCT02555852]4,238,504 participants (Actual)Observational2011-09-30Completed
Cross-over Trial of Medical Treatment for GERD in Preterm Infants [NCT00131248]Phase 318 participants (Actual)Interventional2004-04-30Completed
A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Potential Effects of Ranitidine on the Pharmacokinetics of Lesinurad in Healthy Adult Male Subjects [NCT01908257]Phase 116 participants (Actual)Interventional2013-07-31Completed
Ontogeny of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents [NCT01976078]45 participants (Actual)Observational2012-09-30Completed
Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial [NCT02004197]Phase 2/Phase 3176 participants (Actual)Interventional2010-01-31Completed
Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study. [NCT00590928]Phase 475 participants (Actual)Interventional2004-07-31Completed
An Open-label, Single-center, 2-Part, Randomized Study to Assess the Pharmacokinetics of R406 in Healthy Subjects When Fostamatinib 150 mg is Administered Alone in Fed and Fasted State and in Combination With Ranitidine in Fasted State, and to Assess the [NCT01682408]Phase 128 participants (Actual)Interventional2012-09-30Completed
A Phase 2 Open-Label Study of TPI 287 in Patients With Breast Cancer Metastatic to the Brain [NCT01332630]Phase 224 participants (Actual)Interventional2011-08-16Completed
[NCT00633412]Phase 3400 participants (Anticipated)Interventional2001-02-28Completed
A Clinico-Bacteriological Study and Effect of Stress Ulcer Prophylaxis on Occurrence of Ventilator Associated Pneumonia: a Randomized Prospective Study [NCT00702871]Phase 450 participants (Actual)Interventional2005-03-31Completed
A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects [NCT01392755]Phase 132 participants (Actual)Interventional2011-07-31Completed
A Randomized, Double-blind, Four Period Cross-over Comparison of the Effect of Two Doses Lavoltidine, Esomeprazole, and Placebo on 24 Hour Gastric pH and Frequency of Heartburn in Symptomatic GERD Subjects Without Esophageal Erosions [NCT00405119]Phase 292 participants (Actual)Interventional2006-05-31Completed
Comparative Randomized Controlled Trial Study of General Balanced Anesthesia Based on Opioid and Opioid Sparing Balanced Anesthesia for Cholecystectomy Surgery Via Laparoscopy: Intraoperative and Postoperative Outcomes [NCT02953210]Phase 440 participants (Anticipated)Interventional2016-11-30Enrolling by invitation
A Pilot Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multicenter Trial to Evaluate the Effect of Ranitidine on Immunologic Indicators in Asymptomatic HIV-1 Infected Subjects With a CD4 Cell Count Between 400-700 Cells/mm3 [NCT00002106]Phase 2104 participants InterventionalCompleted
Phase 1 Dose Escalation Study of LY2090314 in Patients With Advanced or Metastatic Cancer in Combination With Pemetrexed and Carboplatin [NCT01287520]Phase 141 participants (Actual)Interventional2007-11-30Completed
Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subj [NCT03011463]Phase 124 participants (Actual)Interventional2016-11-30Completed
YF476: Effects of a Single Dose at 3 Dose Levels on 24-hour Ambulatory Gastric pH Compared With Placebo and Ranitidine in Healthy Volunteers [NCT01538797]Phase 122 participants (Actual)Interventional1996-07-31Completed
A Phase I, Randomized, Open-label, Single-center Study to Assess the Pharmacokinetics of Vandetanib (CAPRELSA) in Healthy Subjects When a Single Oral Dose of Vandetanib 300 mg is Administered Alone and in Combination With Omeprazole or Ranitidine [NCT01539655]Phase 134 participants (Actual)Interventional2012-02-29Completed
Studies of Esophageal Metaplasia Using a Novel Antibody: Reversibility of Columnar Metaplasia by Proton Pump Inhibitor [NCT00161200]Phase 360 participants Interventional2002-12-31Terminated(stopped due to slow accrual)
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL) [NCT02999633]Phase 214 participants (Actual)Interventional2017-03-08Terminated(stopped due to Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely)
A Prospective, Randomized Trial Comparing the Effect of Intravenous Omeprazole to That of Intravenous Ranitidine on the Maintenance of Hemostasis After Successful Endoscopic Treatment of Bleeding Peptic Ulcer [NCT00247130]Phase 40 participants (Actual)Interventional2005-10-31Withdrawn(stopped due to Superiority of iv omeprazole to ranitidine has already been proven by others.)
Comparison of an Antacid/H2-Receptor Antagonist/Proton Pump Inhibitor Versus a Proton Pump Inhibitor/H2-Receptor Antagonist/Antacid Treatment Strategy for Patients With New Onset Dyspepsia in General Practice (The DIAMOND-Study) [NCT00247715]664 participants (Actual)Interventional2003-10-31Completed
Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial. [NCT01737840]Phase 466 participants (Actual)Interventional2012-10-31Completed
The Effect of Increasing Gastric pH Upon the Bioavailability of Orally Administered Phosphonoformic Acid (Foscarnet) [NCT00000964]Phase 16 participants InterventionalCompleted
A Phase II Clinical Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Renal Cell Carcinoma [NCT00030992]Phase 2102 participants (Actual)Interventional2002-02-28Completed
Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study [NCT03140033]Phase 2158 participants (Anticipated)Interventional2016-07-31Recruiting
A Double-Blind, Randomized, Placebo-Controlled Cross-Over Study Assessing the Role of Pathogen-Specific IgE and Histamine Release in the Hyper-IgE Syndrome and the Effect of Ranitidine on Laboratory and Clinical Manifestations [NCT00527878]Phase 216 participants (Actual)Interventional2007-09-30Terminated(stopped due to Failure to enroll adequate patient numbers due to small number of eligible patients)
Possible Drug Interaction Between Clopidogrel and Ranitidin or Omeprazole in Patients With Stable Coronary Heart Disease: a Comparative Study [NCT01896557]Phase 492 participants (Actual)Interventional2011-10-31Completed
A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass [NCT03583567]Phase 440 participants (Actual)Interventional2018-09-05Completed
Histamine Receptor 2 Antagonists as Enhancers of Anti-Tumour Immunity [NCT03145012]Phase 430 participants (Actual)Interventional2018-05-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00030992 (2) [back to overview]Number of Participants With Adverse Events
NCT00030992 (2) [back to overview]Response Rate
NCT00131248 (1) [back to overview]Bradycardia Episodes/Day
NCT00401752 (6) [back to overview]The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.
NCT00401752 (6) [back to overview]Percentage of Participants With the Occurance of Any Adverse Event.
NCT00401752 (6) [back to overview]The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
NCT00401752 (6) [back to overview]The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy
NCT00401752 (6) [back to overview]The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
NCT00401752 (6) [back to overview]The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
NCT00527878 (4) [back to overview]New Skin Infections
NCT00527878 (4) [back to overview]Clinical Severity Score
NCT00527878 (4) [back to overview]New Lung Infections
NCT00527878 (4) [back to overview]Number of Infections in Subjects With HIES.
NCT00585351 (2) [back to overview]Prevention of Chemical Pneumonitis
NCT00585351 (2) [back to overview]The Benefit of Advanced Notification in Promoting Informed Consent
NCT00668317 (1) [back to overview]Change in Methacholine Sensitivity
NCT00838526 (3) [back to overview]Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
NCT00838526 (3) [back to overview]Percentage of Participants With Adverse Events by Category
NCT00838526 (3) [back to overview]Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
NCT00839306 (2) [back to overview]Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
NCT00839306 (2) [back to overview]Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
NCT01287520 (10) [back to overview]PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314
NCT01287520 (10) [back to overview]PK Parameter: Cmax of Free Carboplatin
NCT01287520 (10) [back to overview]PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
NCT01287520 (10) [back to overview]PK Parameter: AUC0-∞ of Free Carboplatin (Carb)
NCT01287520 (10) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314
NCT01287520 (10) [back to overview]Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)
NCT01287520 (10) [back to overview]PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)
NCT01287520 (10) [back to overview]PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)
NCT01287520 (10) [back to overview]Recommended LY2090314 Dose for Phase 2 Studies (Maximum Tolerated Dose [MTD])
NCT01287520 (10) [back to overview]Number of Participants With Best Overall Tumor Response
NCT01332630 (1) [back to overview]Overall Response Rate (ORR)
NCT01737840 (2) [back to overview]Visual Analogue Scale Score
NCT01737840 (2) [back to overview]Need for Additional Drug
NCT01896557 (4) [back to overview]Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment
NCT01896557 (4) [back to overview]Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.
NCT01896557 (4) [back to overview]Comparison of the Primary Outcome With Bioimpedance Aggregometry
NCT01896557 (4) [back to overview]Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)
NCT02999633 (1) [back to overview]Percentage of Participants With Objective Response
NCT04397445 (6) [back to overview]Cumulative Ranitidine Amount Excreted in Urine Over 24 Hours After Drug Administration
NCT04397445 (6) [back to overview]Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Ranitidine and Placebo)
NCT04397445 (6) [back to overview]Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Diets)
NCT04397445 (6) [back to overview]Cumulative Dimethylamine (DMA) Amount Excreted in Urine Over 24 Hours After Drug Administration
NCT04397445 (6) [back to overview]AUC(0-t) of Plasma DMA
NCT04397445 (6) [back to overview]AUC(0-t) of Plasma Ranitidine

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00030992)
Timeframe: 10 years

InterventionParticipants (Number)
BMS-24755099

[back to top]

Response Rate

Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00030992)
Timeframe: 6 weeks

InterventionPercentage of participants (Number)
Complete responsePartial ResponseProgressive diseaseStable disease
BMS-24755019.412.676.8

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Bradycardia Episodes/Day

(NCT00131248)
Timeframe: 7 days

Interventionepisodes per day (Mean)
Medications4.6
Placebo3.6

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The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.

"Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment.~(Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent)." (NCT00401752)
Timeframe: 4 weeks

InterventionPercentage of participants (Number)
Esomeprazole59.4
Ranitidine59.5

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Percentage of Participants With the Occurance of Any Adverse Event.

Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment. (NCT00401752)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Esomeprazole16.8
Ranitidine22.7

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The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.

Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment. (NCT00401752)
Timeframe: 4 and 8 week

InterventionPercentage of participants (Number)
Esomeprazole93.3
Ranitidine81.8

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The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy

Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment. (NCT00401752)
Timeframe: 4 & 8 weeks

InterventionPercentage of participants (Number)
Esomeprazole80.2
Ranitidine69.4

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The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.

Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment. (NCT00401752)
Timeframe: 8 weeks

InterventionPercentage of participants (Number)
Esomeprazole81.1
Ranitidine73.9

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The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.

Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8. (NCT00401752)
Timeframe: week 4 and week 8

InterventionPercentage of participants (Number)
Esomeprazole100
Ranitidine97.7

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New Skin Infections

Patients reported the number of new skin infections (NCT00527878)
Timeframe: 12 months placebo/12 months ranitidine

Interventionskin infections (Median)
Placebo1
Ranitidine0

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Clinical Severity Score

Scoring that was completed every 3 months. Clinical severity scored had outcomes that could range from 0 to 121 with 0 being the least severe and 121 being the most severe. (NCT00527878)
Timeframe: one year on ranitidine and one year on placebo

Interventionscore on a scale (Mean)
Placebo9.8
Ranitidine8.5

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New Lung Infections

Number of new infection while on placebo or study drug (NCT00527878)
Timeframe: 12 months placebo and 12 months ranitidine

Interventionnew lung infections (Median)
Placebo1
Ranitidine0

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Number of Infections in Subjects With HIES.

Patients received one year of treatment medication and one year of placebo. New infections (bacterial, fungal, viral or parasitic) were defined as those requiring an addition or change of an antimicrobial (including topical, oral or intravenous therapies) or those requiring a medical procedure (i.e., incision and drainage of a skin abscess, warm soaks to aid abscess drainage or sinus drainage). (NCT00527878)
Timeframe: 1 year on intervention

Interventioninfections (Median)
Placebo4
Ranitidine4

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Prevention of Chemical Pneumonitis

Number of subjects that did not develop aspiration pneumonia in the intervention group (Ranitidine vs. placebo). (NCT00585351)
Timeframe: Assessed on the day of discharge (average length of stay is approximately 3-7 days)

InterventionParticipants (Number)
Advanced Notification + Ranitidine5
No Advanced Notification + Ranitidine7
Advanced Notification + Placebo6
No Advanced Notification + Placebo3

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Change in Methacholine Sensitivity

"Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20).~To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine" (NCT00668317)
Timeframe: baseline and 8 weeks

Interventionmg/ml (Mean)
Omeprazole and Ranitidine0.598

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Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26

eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. (NCT00838526)
Timeframe: Baseline to Week 26

InterventionPercentage of Participants (Number)
RAN 150mg BID32.9
RAB ER 50mg QD84.9

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Percentage of Participants With Adverse Events by Category

An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product. A treatment emergent AE (TEAE) was any AE beginning on or after the confirmed date of first dose of study medication, up to and including 7 days after the last dose of study medication. A TEAE was considered related to study treatment if a causal relationship between the study treatment and the AE was a reasonable possibility. AEs were graded as severe if they were incapacitating, with inability to work or to perform normal daily activity. Serious AEs (SAEs) were events that resulted in death, were life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or were a congenital anomaly/birth defect. (NCT00838526)
Timeframe: From the time of administration of the first dose of study drug up to a maximum of approximately 30 weeks.

,
InterventionPercentage of participants (Number)
Any TEAETreatment-related TEAESevere TEAESevere, treatment-related TEAEDeathOther SAETreatment-related SAETEAEs leading to discontinuation of treatment
RAB ER 50mg QD64.214.58.10.606.406.9
RAN 150mg BID47.58.53.41.701.706.8

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Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26

Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities). (NCT00838526)
Timeframe: Baseline to Week 26

,
InterventionPercentage of Participants (Number)
YesNoMissing
RAB ER 50mg QD57.418.823.9
RAN 150mg BID8.525.466.1

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Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26

"eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal mucosa (however, edema, erythema, or friability may be present).~Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds.~Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference.~Grade D: Mucosal breaks involving at least 75% of the esophageal circumference." (NCT00839306)
Timeframe: Baseline to Week 26

InterventionPercentage of Participants (Number)
RAN 150mg BID31.7
RAB ER 50mg QD88.4

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Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26

Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities). (NCT00839306)
Timeframe: Baseline to Week 26

,
InterventionPercentage of Participants (Number)
YesNoMissing
RAB ER 50mg QD53.717.528.8
RAN 150mg BID8.316.775

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PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314

(NCT01287520)
Timeframe: Cycle 1 Day 1 of a 28-day cycle

Interventionnanograms per milliliter (Geometric Mean)
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)122
LY 20/Carb 6/Pem 500 (Cohort 3)246
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9 )603
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7898
LY 120/Carb 6/Pem 500 (Cohort 6)1700
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)881

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PK Parameter: Cmax of Free Carboplatin

Cmax of free Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1, Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle

Interventionnanograms/milliliter/milligram (Geometric Mean)
Carboplatin (Doublet Therapy)24.0
Carboplatin (Triplet Therapy)25.5

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PK Parameter: AUC0-∞ of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)

AUC0-∞ was calculated from the area under the concentration versus time curves of LY2090314 from time zero to infinity when coadministered with Pem and Carb. (NCT01287520)
Timeframe: Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle

Interventionnanograms*hour per milliliter (Geometric Mean)
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)192
LY 20/Carb 6/Pem 500 (Cohort 3)404
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)938
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)1830
LY 120/Carb 6/Pem 500 (Cohort 6)2190
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)1570

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PK Parameter: AUC0-∞ of Free Carboplatin (Carb)

AUC0-∞ of free Carb was calculated from the area under the concentration versus time curves of Carb given as a single dose with Pem (doublet therapy) and when co-administered with Pem and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 9: Day 1 of 21-day cycle

Interventionhours*nanograms per milliliter per mg (Geometric Mean)
Carboplatin (Doublet Therapy)81.6
Carboplatin (Triplet Therapy)88.1

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Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of LY2090314

AUC0-∞ was calculated from the area under the concentration versus time curve from time 0 to infinity of LY2090314 when administered alone. (NCT01287520)
Timeframe: Cycle 1 Day 1 of a 28 day cycle

Interventionnanograms*hour per milliliter (Geometric Mean)
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)216
LY 20/Carb 6/Pem 500 (Cohort 3)427
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)976
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)1870
LY 120/Carb 6/Pem 500 (Cohort 6)3310
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)1600

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Pharmacokinetic (PK) Parameter: Area Under the Concentration-Time Curve From Time 0 Hour to Infinity (AUC0-∞) of Pemetrexed (Pem)

AUC0-∞ was calculated from the area under the concentration versus time curves of Pem given as a single dose with Carb (doublet therapy) and when co-administered with Carb and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle

Interventionhours*nanograms/milliliter/ milligram (Geometric Mean)
Pemetrexed (Doublet Therapy)212
Pemetrexed (Triplet Therapy)202

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PK Parameter: Maximum Plasma Concentration (Cmax) of LY2090314 Coadministered With Pemetrexed (Pem) and Carboplatin (Carb)

(NCT01287520)
Timeframe: Cycle 1 Day 8 of a 28-day cycle or Cycle 2 Day 1 of a 21-day cycle

Interventionnanograms per milliliter (Geometric Mean)
LY 10/Carb 5 or Carb 6/Pem 500 (Cohorts 1 and 2)106
LY 20/Carb 6/Pem 500 (Cohort 3)271
LY 40/Carb 6/Pem 500 (Cohorts 4 and 9)657
LY 80/Carb 6/Pem 500 (Cohorts 5 and 7)1150
LY 120/Carb 6/Pem 500 (Cohort 6)768
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)1040

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PK Parameter: Maximum Plasma Concentration (Cmax) of Pemetrexed (Pem)

Cmax of Pem given as a single dose with Carb (doublet therapy) and when coadministered with Carb and LY2090314 (triplet therapy). (NCT01287520)
Timeframe: Cycle 1 Day 8 of 28-day cycle and Cycle 2 up to Cycle 10 Day 1 of 21-day cycle

Interventionnanogram per milliliter per milligram (Geometric Mean)
Pemetrexed (Doublet Therapy)109
Pemetrexed (Triplet Therapy)108

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Number of Participants With Best Overall Tumor Response

Best overall observed tumor response at any point during the study until disease progression/recurrence defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as at least 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase over nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria. (NCT01287520)
Timeframe: Baseline up to Cycle 9 (Cycle 1 was 28 days, Cycles 2 to 9 were 21 days)

,,,,,,,,
Interventionparticipants (Number)
CRPRSDPDUnknown (discontinued before response assessment)
LY 10/Carb 5/Pem 500 (Cohort 1)00201
LY 10/Carb 6/Pem 500 (Cohort 2)00421
LY 120/Carb 6/Pem 500 (Cohort 6)00000
LY 20/Carb 6/Pem 500 (Cohort 3)01211
LY 40/Carb 6/Pem 500 (Cohort 4)01230
LY 40/Carb 6/Pem 500 + R50 (Cohort 9)00221
LY 60/Carb 6/Pem 500 + R50 (Cohort 8)01120
LY 80/Carb 6/Pem 500 (Cohort 5)00012
LY 80/Carb 6/Pem 500 + R50 (Cohort 7)01100

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Overall Response Rate (ORR)

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01332630)
Timeframe: 8-24 weeks

InterventionParticipants (Count of Participants)
TPI 28721

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Visual Analogue Scale Score

The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain. (NCT01737840)
Timeframe: 30th and 60th minutes

,
InterventionVisual Analogue Scale (Mean)
VAS score changes at 60 minutesVAS scores changes at 30 minutes
Pantoprazole39.627.6
Ranitidine42.328.3

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Need for Additional Drug

The investigators are measuring the need for additional drug at the end of 60 minutes. (NCT01737840)
Timeframe: 60 th minute

Interventionparticipants (Number)
Pantoprazole13
Ranitidine8

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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment

One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units. (NCT01896557)
Timeframe: One week after randomized treatment exposure (omeprazole or ranitidine)

InterventionP2Y12 Reactivity Units (Mean)
Omeprazole173.54
Ranitidine153.61

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Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.

One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative. (NCT01896557)
Timeframe: One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline

InterventionPercentage (Mean)
Omeprazole17.4
Ranitidine30.1

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Comparison of the Primary Outcome With Bioimpedance Aggregometry

After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: bioimpedance aggregometry with ADP 10 mcM as reagent (NCT01896557)
Timeframe: 1 week after drug exposure

InterventionOhms (Mean)
Omeprazole2
Ranitidine2.77

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Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)

After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: PFA-100(Collagen/ADP cartridge). (NCT01896557)
Timeframe: 1 week after drug exposure

Interventionseconds (Mean)
Omeprazole95.1
Ranitidine97.2

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Percentage of Participants With Objective Response

Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC. (NCT02999633)
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)

Interventionpercentage of participants (Number)
Isatuximab0

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Cumulative Ranitidine Amount Excreted in Urine Over 24 Hours After Drug Administration

The cumulative amount of ranitidine excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.

Interventionmilligrams (Geometric Mean)
Ranitidine and Cured Meats Diet91.7
Ranitidine and Noncured Meats Diet74.1

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Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Ranitidine and Placebo)

The cumulative amount of NDMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.

Interventionnanograms (Median)
Ranitidine and Noncured Meats Diet0.6
Placebo and Noncured Meats Diet10.5
Ranitidine and Cured Meats Diet11.9
Placebo and Cured Meats Diet23.4

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Cumulative NDMA Amount Excreted in Urine Over 24 Hours After Drug Administration (Comparison Between Diets)

The cumulative amount of NDMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.

Interventionnanograms (Median)
Ranitidine and Cured Meats Diet11.9
Ranitidine and Noncured Meats Diet0.6
Placebo and Cured Meats Diet23.4
Placebo and Noncured Meats Diet10.5

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Cumulative Dimethylamine (DMA) Amount Excreted in Urine Over 24 Hours After Drug Administration

The cumulative amount of DMA excreted over 24 hours is determined by calculating the amount excreted during specified intervals (includes all planned collections and unscheduled voids) and summarizing totals over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose including planned collections (at 3, 6, 9, 12, 15, and 24 hours post-dose) and unscheduled voids. All subjects voided at approximately 0 hours (pre-dose), which was not included in the assessment.

Interventionmilligrams (Geometric Mean)
Ranitidine and Noncured Meats Diet38.8
Placebo and Noncured Meats Diet41.1
Ranitidine and Cured Meats Diet40.7
Placebo and Cured Meats Diet43.1

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AUC(0-t) of Plasma DMA

Determined for each subject using non-compartmental methods. All parameters will be reported with standard descriptive statistics including the geometric mean and coefficient of variation. Calculation of pharmacokinetic parameters will be performed using actual sampling times over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose with planned samples at 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 11, 14, and 24 h post-dose

Interventionmicrograms*hour/milliliter (Geometric Mean)
Ranitidine and Noncured Meats Diet26.3
Placebo and Noncured Meats Diet26.2
Ranitidine and Cured Meats Diet20.9
Placebo and Cured Meats Diet20.9

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AUC(0-t) of Plasma Ranitidine

Determined for each subject using non-compartmental methods. All parameters will be reported with standard descriptive statistics including the geometric mean and coefficient of variation. Calculation of pharmacokinetic parameters will be performed using actual sampling times over a 24-h period. (NCT04397445)
Timeframe: 24-hours post-dose with planned samples at 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 11, 14, and 24 h post-dose

Interventionnanograms*hour/milliliter (Geometric Mean)
Ranitidine and Cured Meats Diet3736
Ranitidine and Noncured Meats Diet4857

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