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A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

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ClinicalTrials.gov Identifier: NCT00762359
Recruitment Status : Terminated (AG-1749 superior to Gefarnate in ulcer prevention)
First Posted : September 30, 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 461
Recruitment Details Participants were enrolled at sites in Japan from May 2007 to November 2008.
Pre-assignment Details Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups.
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 12 to 30 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Period Title: Overall Study
Started 226 235
Completed 167 178
Not Completed 59 57
Reason Not Completed
Adverse Event             20             23
Protocol Violation             21             13
Withdrawal by Subject             13             10
Lack of Efficacy             0             4
Institution closed             2             3
Physician Decision             2             3
Removal             0             1
Withdrew consent             1             0
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 12 to 30 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months. Total of all reporting groups
Overall Number of Baseline Participants 226 235 461
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 226 participants 235 participants 461 participants
<=39 years 1 0 1
Between 40 and 49 years 1 4 5
Between 50 and 59 years 31 36 67
Between 60 and 64 years 28 32 60
Between 65 and 69 years 38 53 91
Between 70 and 79 years 105 81 186
<=80 years 22 29 51
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 235 participants 461 participants
Female
51
  22.6%
43
  18.3%
94
  20.4%
Male
175
  77.4%
192
  81.7%
367
  79.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 226 participants 235 participants 461 participants
226 235 461
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 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time Frame 18 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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 226 234
Measure Type: Number
Unit of Measure: participants
6 53
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 0.0989
Confidence Interval (2-Sided) 95%
0.0425 to 0.2300
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 213 215
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.150  (0.904) 0.460  (1.241)
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]
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 170 134
Median (Standard Deviation)
Unit of Measure: scores on a scale
-0.153  (1.172) 0.530  (1.444)
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]
4.Secondary Outcome
Title Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
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 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 87 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.149  (1.157) 0.419  (1.375)
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 0.0079
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 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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 67 44
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.224  (1.112) 0.205  (1.047)
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 0.0433
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 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
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 212 215
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.132  (0.552) 0.228  (0.755)
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 170 134
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.165  (0.583) 0.149  (0.741)
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 0.0006
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 9)
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 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 87 74
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.092  (0.542) 0.216  (0.688)
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 0.0025
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 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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 67 44
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.254  (0.766) 0.136  (0.409)
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 0.0010
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 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
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
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 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time Frame 18 Months
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 226 234
Measure Type: Number
Unit of Measure: participants
7 56
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.005  (0.187) 0.015  (0.295)
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 0.6148
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.025  (0.158) -0.030  (0.171)
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 0.8050
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.027  (0.163) -0.023  (0.152)
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 0.8678
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.020  (0.143) -0.071  (0.262)
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 0.2688
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.333  (0.577) -1.000 [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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.005  (0.307) 0.026  (0.357)
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 0.7054
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.038  (0.192) -0.008  (0.261)
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 0.3400
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.027  (0.211) -0.023  (0.152)
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 0.8813
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.204) -0.071  (0.262)
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 0.1862
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.333  (0.577) -1.000 [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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.020  (0.315) -0.005  (0.312)
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 0.8604
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.019  (0.329) 0.015  (0.325)
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 0.5485
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.027  (0.368) -0.023  (0.265)
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 0.7382
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.020  (0.143) -0.036  (0.331)
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 0.7619
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA) 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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.025  (0.233) 0.020  (0.142)
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 0.0204
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.051  (0.220) 0.008  (0.087)
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 0.0046
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.072  (0.260) 0.012  (0.108)
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 0.0059
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.082  (0.277) 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 0.1229
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA) 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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.064  (0.387) -0.005  (0.411)
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 0.2694
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.089  (0.346) 0.038  (0.451)
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 0.0141
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.063  (0.411) 0.000  (0.376)
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 0.3128
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.163  (0.373) -0.036  (0.331)
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 0.1450
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA) NA [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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.005  (0.254) 0.010  (0.175)
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 0.6175
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.019  (0.177) 0.000  (0.246)
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 0.4496
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
40.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.018  (0.190) 0.000  (0.153)
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 0.4718
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
41.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
0.000  (0.204) -0.036  (0.189)
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 0.4484
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
42.Secondary Outcome
Title Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.333  (0.577) 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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 202 196
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.010  (0.099) 0.020  (0.286)
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 0.2604
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 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 158 133
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.006  (0.138) 0.000  (0.123)
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 0.6818
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 9)
Hide Description 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.
Time Frame Baseline and Month 9.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 111 86
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.009  (0.165) -0.012  (0.108)
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 0.9015
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 12)
Hide Description 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.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 49 28
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.020  (0.143) 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 0.4497
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 18)
Hide Description 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.
Time Frame Baseline and Month 18.
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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: scores on a scale
NA [1]   (NA) 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 18 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 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Overall Number of Participants Analyzed 226 234
Measure Type: Number
Unit of Measure: participants
Adverse event 166 168
Adverse event (Frequency ≥5%) 82 68
Adverse event related to the study drug 26 25
Serious adverse event 27 26
Serious adverse event related to the study drug 0 1
Time Frame Adverse events were summarized by onset date occurring on or after the first dose of 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 12 to 30 months. Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 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   27/226 (11.95%)   26/234 (11.11%) 
Cardiac disorders     
Angina pectoris  1  4/226 (1.77%)  3/234 (1.28%) 
Atrial fibrillation  1  0/226 (0.00%)  1/234 (0.43%) 
Ear and labyrinth disorders     
Sudden hearing loss  1  1/226 (0.44%)  0/234 (0.00%) 
Eye disorders     
Cataract  1  1/226 (0.44%)  1/234 (0.43%) 
Corneal degeneration  1  0/226 (0.00%)  1/234 (0.43%) 
Retinal detachment  1  0/226 (0.00%)  1/234 (0.43%) 
Gastrointestinal disorders     
Colonic polyp  1  1/226 (0.44%)  1/234 (0.43%) 
Gastric ulcer haemorrhage  1  0/226 (0.00%)  2/234 (0.85%) 
Alcoholic pancreatitis  1  1/226 (0.44%)  0/234 (0.00%) 
Subileus  1  1/226 (0.44%)  0/234 (0.00%) 
Gastritis  1  1/226 (0.44%)  0/234 (0.00%) 
Gastrointestinal haemorrhage  1  0/226 (0.00%)  1/234 (0.43%) 
Colitis ischaemic  1  0/226 (0.00%)  1/234 (0.43%) 
Gastritis haemorrhagic  1  0/226 (0.00%)  1/234 (0.43%) 
Duodenal ulcer haemorrhage  1  0/226 (0.00%)  1/234 (0.43%) 
Small intestinal haemorrhage  1  1/226 (0.44%)  0/234 (0.00%) 
Abdominal pain upper  1  1/226 (0.44%)  0/234 (0.00%) 
Inguinal hernia  1  1/226 (0.44%)  0/234 (0.00%) 
General disorders     
Chest discomfort  1  1/226 (0.44%)  0/234 (0.00%) 
Cyst  1  1/226 (0.44%)  0/234 (0.00%) 
Hepatobiliary disorders     
Liver disorder  1  0/226 (0.00%)  1/234 (0.43%) 
Cholecystitis acute  1  0/226 (0.00%)  1/234 (0.43%) 
Infections and infestations     
Pneumonia  1  1/226 (0.44%)  1/234 (0.43%) 
Urinary tract infection  1  1/226 (0.44%)  0/234 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  2/226 (0.88%)  0/234 (0.00%) 
Road traffic accident  1  0/226 (0.00%)  1/234 (0.43%) 
Meniscus lesion  1  0/226 (0.00%)  1/234 (0.43%) 
Tibia fracture  1  1/226 (0.44%)  0/234 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/226 (0.00%)  1/234 (0.43%) 
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  1/226 (0.44%)  1/234 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer  1  2/226 (0.88%)  0/234 (0.00%) 
Gastric cancer  1  1/226 (0.44%)  0/234 (0.00%) 
Pharyngeal cancer stage unspecified  1  0/226 (0.00%)  1/234 (0.43%) 
Breast cancer female  1  1/226 (0.44%)  0/234 (0.00%) 
Oesophageal carcinoma  1  0/226 (0.00%)  1/234 (0.43%) 
Large intestine carcinoma  1  0/226 (0.00%)  1/234 (0.43%) 
Lung adenocarcinoma  1  1/226 (0.44%)  0/234 (0.00%) 
Nervous system disorders     
Cerebral infarction  1  1/226 (0.44%)  2/234 (0.85%) 
Cerebral haemorrhage  1  0/226 (0.00%)  1/234 (0.43%) 
Hemiplegia  1  1/226 (0.44%)  0/234 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/226 (0.44%)  0/234 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/226 (0.44%)  0/234 (0.00%) 
Vascular disorders     
Hypertension  1  1/226 (0.44%)  0/234 (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   82/226 (36.28%)   68/234 (29.06%) 
Gastrointestinal disorders     
Constipation  1  14/226 (6.19%)  8/234 (3.42%) 
Diarrhoea  1  19/226 (8.41%)  2/234 (0.85%) 
Reflux oesophagitis  1  3/226 (1.33%)  16/234 (6.84%) 
Infections and infestations     
Nasopharyngitis  1  51/226 (22.57%)  45/234 (19.23%) 
Injury, poisoning and procedural complications     
Fall  1  13/226 (5.75%)  9/234 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.
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: NCT00762359     History of Changes
Other Study ID Numbers: AG-1749-CCT-351
070494 ( Registry Identifier: JapicCTI )
U1111-1113-9929 ( Registry Identifier: WHO )
R100125 ( Registry Identifier: JapicCTI )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: February 3, 2011
Results First Posted: May 10, 2011
Last Update Posted: February 3, 2012