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Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

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ClinicalTrials.gov Identifier: NCT00787254
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : May 10, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stomach Ulcer
Duodenal Ulcer
Interventions Drug: Lansoprazole
Drug: Gefarnate
Enrollment 366
Recruitment Details Participants were enrolled at sites in Japan from April 2007 to May 2009.
Pre-assignment Details Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups. NSAID = Nonsteroidal anti-inflammatory drug.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Period Title: Overall Study
Started 185 181
Completed 109 99
Not Completed 76 82
Reason Not Completed
Adverse Event             24             23
Protocol Violation             26             23
Withdrawal by Subject             16             11
Lack of Efficacy             4             15
NSAIDs discontinuation             1             2
Institution closed             1             0
Physician Decision             4             8
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID Total
Hide Arm/Group Description Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months. Total of all reporting groups
Overall Number of Baseline Participants 185 181 366
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 181 participants 366 participants
≤39 years 7 6 13
Between 40 and 49 years 18 13 31
Between 50 and 59 years 38 43 81
Between 60 and 64 years 33 29 62
Between 65 and 69 years 33 30 63
Between 70 and 79 years 43 48 91
≤80 years 13 12 25
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 181 participants 366 participants
Female
112
  60.5%
107
  59.1%
219
  59.8%
Male
73
  39.5%
74
  40.9%
147
  40.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 185 participants 181 participants 366 participants
185 181 366
1.Primary Outcome
Title Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
Hide Description 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.
Time Frame 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants not taking investigational drug were not included.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 183 181
Measure Type: Number
Unit of Measure: participants
15 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.2510
Confidence Interval (2-Sided) 95%
0.1400 to 0.4499
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 167 154
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.114  (1.020) 0.429  (1.318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 116 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.319  (1.060) 0.188  (1.268)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0041
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 78 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.231  (1.299) 0.048  (1.137)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0652
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 37 18
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.162  (1.280) -0.278  (1.227)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9836
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 5 2
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.800  (1.304) NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
7.Secondary Outcome
Title Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 167 155
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.102  (0.499) 0.142  (0.649)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 116 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.095  (0.527) 0.047  (0.373)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 79 62
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.177  (0.675) 0.048  (0.381)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 37 18
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.297  (0.812) -0.056  (0.539)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2363
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 5 2
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.200  (0.447) NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
12.Secondary Outcome
Title Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Hide Description 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.
Time Frame On occurrence (up to month 24).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 183 181
Measure Type: Number
Unit of Measure: participants
15 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.006  (0.178) 0.014  (0.319)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4788
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.027  (0.285) 0.000  (0.347)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6607
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.014  (0.208) -0.020  (0.249)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8811
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.000) 0.000  (0.000)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
18.Secondary Outcome
Title Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.044  (0.326) 0.014  (0.400)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2060
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.009  (0.393) -0.036  (0.424)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5099
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.029  (0.416) -0.061  (0.317)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7794
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.000) 0.000  (0.447)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
23.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.025  (0.318) -0.014  (0.452)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6980
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
24.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.381) -0.048  (0.408)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4599
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.057  (0.336) -0.204  (0.407)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0355
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.056  (0.416) 0.000  (0.447)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7325
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
28.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.006  (0.239) 0.007  (0.308)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8262
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.009  (0.286) -0.012  (0.245)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7244
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.043  (0.204) -0.041  (0.200)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9566
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.000) -0.091  (0.302)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2008
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
33.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.057  (0.378) 0.058  (0.625)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0703
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.027  (0.476) -0.095  (0.428)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3046
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
35.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.114  (0.363) -0.102  (0.510)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7121
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
36.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.056  (0.236) 0.091  (0.302)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1522
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.000 [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
38.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.006  (0.138) 0.022  (0.283)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5328
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
39.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.036  (0.187) 0.024  (0.268)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7223
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
40.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.014  (0.208) -0.020  (0.143)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3117
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
41.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.056  (0.236) 0.000  (0.000)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4344
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
42.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
43.Secondary Outcome
Title Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
Hide Description 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.
Time Frame Baseline and Month 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 158 138
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.006  (0.080) -0.007  (0.085)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1571
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
44.Secondary Outcome
Title Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
Hide Description 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.
Time Frame Baseline and Month 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 111 84
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.000) 0.012  (0.109)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2503
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
45.Secondary Outcome
Title Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
Hide Description 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.
Time Frame Baseline and Month 12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 70 49
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.043  (0.359) 0.000  (0.000)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4028
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
46.Secondary Outcome
Title Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 18 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.000) 0.000  (0.000)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lansoprazole 15 mg QD, Gefarnate 50 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
47.Secondary Outcome
Title Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
Hide Description 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.
Time Frame Baseline and Month 24.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA)
[1]
No test was performed when the number of cases was 5 or less.
48.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description 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.
Time Frame Per Incidence (up to 24 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description:
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Overall Number of Participants Analyzed 183 181
Measure Type: Number
Unit of Measure: participants
Adverse Event 154 125
Adverse event (Frequency ≥5%) 83 64
Adverse event related to the study drug 28 28
Serious adverse event 29 17
Serious adverse event related to the study drug 2 1
Time Frame Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication, and up to 24 months after the permanent discontinuation of the double-blind study medication.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Lansoprazole 15 mg QD Gefarnate 50 mg BID
Hide Arm/Group Description Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
All-Cause Mortality
Lansoprazole 15 mg QD Gefarnate 50 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lansoprazole 15 mg QD Gefarnate 50 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   29/183 (15.85%)   17/181 (9.39%) 
Blood and lymphatic system disorders     
Anemia  1  1/183 (0.55%)  0/181 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/183 (0.55%)  0/181 (0.00%) 
Myocardial infarction  1  1/183 (0.55%)  0/181 (0.00%) 
Cardiac failure  1  0/183 (0.00%)  1/181 (0.55%) 
Eye disorders     
Retinal vein occlusion  1  1/183 (0.55%)  0/181 (0.00%) 
Gastrointestinal disorders     
Colonic polyp  1  3/183 (1.64%)  0/181 (0.00%) 
Inguinal hernia  1  1/183 (0.55%)  2/181 (1.10%) 
Gastric ulcer  1  0/183 (0.00%)  1/181 (0.55%) 
Pancreatitis necrotising  1  1/183 (0.55%)  0/181 (0.00%) 
Duodenitis  1  1/183 (0.55%)  0/181 (0.00%) 
Enterocolitis  1  0/183 (0.00%)  1/181 (0.55%) 
Intestinal obstruction  1  1/183 (0.55%)  0/181 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  1/183 (0.55%)  0/181 (0.00%) 
Infections and infestations     
Pneumonia  1  2/183 (1.09%)  0/181 (0.00%) 
Pyelonephritis  1  1/183 (0.55%)  0/181 (0.00%) 
Herpes zoster  1  1/183 (0.55%)  0/181 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  4/183 (2.19%)  1/181 (0.55%) 
Medical device pain  1  1/183 (0.55%)  0/181 (0.00%) 
Hip fracture  1  0/183 (0.00%)  1/181 (0.55%) 
Road traffic accident  1  1/183 (0.55%)  0/181 (0.00%) 
Spinal compression fracture  1  0/183 (0.00%)  1/181 (0.55%) 
Meniscus lesion  1  0/183 (0.00%)  1/181 (0.55%) 
Investigations     
Blood creatinine increased  1  1/183 (0.55%)  0/181 (0.00%) 
Metabolism and nutrition disorders     
Hyponatremia  1  1/183 (0.55%)  0/181 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis  1  0/183 (0.00%)  2/181 (1.10%) 
Musculoskeletal pain  1  0/183 (0.00%)  1/181 (0.55%) 
Osteonecrosis  1  0/183 (0.00%)  1/181 (0.55%) 
Osteoarthritis  1  1/183 (0.55%)  0/181 (0.00%) 
Intervertebral disc protrusion  1  0/183 (0.00%)  1/181 (0.55%) 
Collagen disorder  1  0/183 (0.00%)  1/181 (0.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Gastric cancer  1  3/183 (1.64%)  0/181 (0.00%) 
Colon neoplasm  1  0/183 (0.00%)  1/181 (0.55%) 
Prostate cancer  1  0/183 (0.00%)  1/181 (0.55%) 
Large intestine carcinoma  1  1/183 (0.55%)  0/181 (0.00%) 
Ovarian neoplasm  1  1/183 (0.55%)  0/181 (0.00%) 
Pancreatic carcinoma  1  0/183 (0.00%)  1/181 (0.55%) 
Renal and urinary disorders     
Nephrotic syndrome  1  1/183 (0.55%)  0/181 (0.00%) 
Calculus ureteric  1  0/183 (0.00%)  1/181 (0.55%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  0/183 (0.00%)  2/181 (1.10%) 
Vascular disorders     
Varicose vein  1  1/183 (0.55%)  0/181 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lansoprazole 15 mg QD Gefarnate 50 mg BID
Affected / at Risk (%) Affected / at Risk (%)
Total   83/183 (45.36%)   64/181 (35.36%) 
Gastrointestinal disorders     
Diarrhea  1  19/183 (10.38%)  5/181 (2.76%) 
Reflux esophagitis  1  4/183 (2.19%)  12/181 (6.63%) 
Constipation  1  10/183 (5.46%)  10/181 (5.52%) 
Infections and infestations     
Nasopharyngitis  1  51/183 (27.87%)  37/181 (20.44%) 
Injury, poisoning and procedural complications     
Fall  1  12/183 (6.56%)  10/181 (5.52%) 
Skin and subcutaneous tissue disorders     
Eczema  1  10/183 (5.46%)  5/181 (2.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
This study was prematurely discontinued due to results available from a parallel study (AG-1749-CCT-351; NCT00762359) demonstrating a preventive effect on ulcer occurrence which impacted the risk/benefit profile.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
Results Point of Contact
Name/Title: Sr. VP Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00787254     History of Changes
Other Study ID Numbers: AG-1749-CCT-352
070495 ( Registry Identifier: JapicCTI )
U1111-1114-2071 ( Registry Identifier: WHO )
R100126 ( Registry Identifier: JapicCTI )
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: February 3, 2011
Results First Posted: May 10, 2011
Last Update Posted: February 3, 2012