Page last updated: 2024-12-10

gefarnate

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

Description

Gefarnate: A water insoluble terpene fatty acid used in the treatment of gastrointestinal ulcers; it facilitates the healing and function of mucosal tissue. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID5282182
CHEMBL ID2105085
CHEBI ID31646
SCHEMBL ID148495
MeSH IDM0009050

Synonyms (59)

Synonym
AC-2134
osteol
nsc-138947
nsc138947
5,9,13-trimethyl-4,8,12-tetradecatrienoic acid 3,7-dimethyl-2,6-octadienyl ester
geranyl farnesylacetate
51-77-4
[(2e)-3,7-dimethylocta-2,6-dienyl] (4e,8e)-5,9,13-trimethyltetradeca-4,8,12-trienoate
gefarnato [inn-spanish]
4,8,12-tetradecatrienoic acid, 5,9,13-trimethyl-, (2e)-3,7-dimethyl-2,6-octadienyl ester, (4e,8e)-
gefarnyl
da-688
gefarnatum [inn-latin]
gefarnil
4,8,12-tetradecatrienoic acid, 5,9,13-trimethyl-, 3,7-dimethyl-2,6-octadienyl ester, (e,e,e)-
einecs 200-121-0
gefarnate
(e,e,e)-5,9,13-trimethyl-4,8,12-tetradecatrienoic acid 3,7-dimethyl-2,6-octadienyl ester
trans-3,7-dimethyl-2,6-octadienyl 5,9,13-trimethyl-4,8,12-tetradecatrienoate
gefarnate [inn:ban:jan]
111GE003
3,7-dimethylocta-2,6-dien-1-yl 5,9,13-trimethyltetradeca-4,8,12-trienoate
3,7-dimethylocta-2,6-dienyl 5,9,13-trimethyltetradeca-4,8,12-trienoate
NCGC00182546-01
tox21_112983
dtxcid7028562
dtxsid0048636 ,
cas-51-77-4
4,8,12-tetradecatrienoic acid, 5,9,13-trimethyl-, (2e)-3,7-dimethyl-2,6-octadien-1-yl ester, (4e,8e)-
gefarnatum
1ise2y6ula ,
da 688
unii-1ise2y6ula
gefarnato
gefanil
CHEMBL2105085
AKOS015966756
gefarnate [mi]
gefarnate [who-dd]
gefarnate [jan]
gefarnate [mart.]
gefarnate [inn]
S5477
SCHEMBL148495
tox21_112983_1
NCGC00182546-02
CS-7652
CHEBI:31646
DB12079
HY-B2206
Q5530013
mfcd00129086
(4e,8e)-(e)-3,7-dimethylocta-2,6-dien-1-yl 5,9,13-trimethyltetradeca-4,8,12-trienoate
AS-15887
geranyl-farnesylacetate
CCG-268656
C75428
(e)-3,7-dimethylocta-2,6-dien-1-yl (4e,8e)-5,9,13-trimethyltetradeca-4,8,12-trienoate
AKOS040759157

Research Excerpts

Actions

ExcerptReferenceRelevance
"Gefarnate promotes goblet cell repopulation and increases mucin production after a conjunctival injury. "( Effect of gefarnate on the ocular surface in squirrel monkeys.
Beuerman, RW; Hamano, T; Nakamura, M; Nakata, K; Nguyen, D; Toshida, H, 2002
)
2.16

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
organic molecular entityAny molecular entity that contains carbon.
[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 (1)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
estrogen nuclear receptor alphaHomo sapiens (human)Potency6.74000.000229.305416,493.5996AID743069
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (52)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (60)

TimeframeStudies, This Drug (%)All Drugs %
pre-199031 (51.67)18.7374
1990's8 (13.33)18.2507
2000's3 (5.00)29.6817
2010's11 (18.33)24.3611
2020's7 (11.67)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 28.53

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 moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index28.53 (24.57)
Research Supply Index4.33 (2.92)
Research Growth Index5.15 (4.65)
Search Engine Demand Index44.28 (26.88)
Search Engine Supply Index2.50 (0.95)

This Compound (28.53)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials10 (15.38%)5.53%
Reviews3 (4.62%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other52 (80.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Lipid-lowering Effects of Gefarnate in Statin-treated Coronary Heart Disease Patients With Residual Hypertriglyceridemia [NCT03610321]Phase 2/Phase 370 participants (Anticipated)Interventional2019-09-01Enrolling by invitation
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 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)
Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study [NCT01051388]Phase 3280 participants (Actual)Interventional2008-08-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
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 Hunger and Nighttime 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 6)
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)
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 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 Postprandial Pain Gastrointestinal Symptom (Month 12)
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 Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
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 9)
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]Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
NCT00762359 (46) [back to overview]Number of Participants With Adverse Events
NCT00787254 (48) [back to overview]Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
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 Duodenal 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 18)
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 3)
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 Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
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 24)
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 6)
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 12)
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 3)
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 Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
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 Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
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 Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
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 Heartburn Gastrointestinal Symptom (Month 18)
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 3)
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 Nausea 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 Feeling of Nausea Gastrointestinal Symptom (Month 24)
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 6)
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 Hematemesis and Melena Gastrointestinal Symptom (Month 18)
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 3)
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 Hematemesis and Melena Gastrointestinal Symptom (Month 6)
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 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)
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 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 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)

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 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 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 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 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 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 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 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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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 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 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 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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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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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 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 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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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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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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