Duodenal Ulcer, Stomach Ulcer
Conditions
Keywords
Curling Ulcer, Gastric Ulcer, Aspirin, Acetylsalicylic Acid, Drug Therapy
Brief summary
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.
Detailed description
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death. The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.
Interventions
DRUGLansoprazole
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
DRUGGefarnate
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started. * The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.
Exclusion criteria
* Endoscopically confirmed gastric and/or duodenal ulcers on Day 1. * Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1. * Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs. * Past or planned surgery affecting gastric acid secretion. * Clinically significant hepatic or renal disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 18 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | Baseline and Month 18. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | Baseline and Month 6. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | Baseline and Month 9. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | Baseline and Month 12. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | Baseline and Month 18. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 18 Months | 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. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | Baseline and Month 3. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9) | Baseline and Month 9. | Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Number of Participants With Adverse Events | 18 Months | 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. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
Countries
Japan
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Lansoprazole 15 mg QD Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months. | 226 |
| Gefarnate 50 mg BID Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months. | 235 |
| Total | 461 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 20 | 23 |
| Overall Study | Institution closed | 2 | 3 |
| Overall Study | Lack of Efficacy | 0 | 4 |
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Protocol Violation | 21 | 13 |
| Overall Study | Removal | 0 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 10 |
| Overall Study | Withdrew consent | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Gefarnate 50 mg BID | Lansoprazole 15 mg QD |
|---|---|---|---|
| Age, Customized <=39 years | 1 participants | 0 participants | 1 participants |
| Age, Customized <=80 years | 51 participants | 29 participants | 22 participants |
| Age, Customized Between 40 and 49 years | 5 participants | 4 participants | 1 participants |
| Age, Customized Between 50 and 59 years | 67 participants | 36 participants | 31 participants |
| Age, Customized Between 60 and 64 years | 60 participants | 32 participants | 28 participants |
| Age, Customized Between 65 and 69 years | 91 participants | 53 participants | 38 participants |
| Age, Customized Between 70 and 79 years | 186 participants | 81 participants | 105 participants |
| Region of Enrollment Japan | 461 participants | 235 participants | 226 participants |
| Sex: Female, Male Female | 94 Participants | 43 Participants | 51 Participants |
| Sex: Female, Male Male | 367 Participants | 192 Participants | 175 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 82 / 226 | 68 / 234 |
| serious Total, serious adverse events | 27 / 226 | 26 / 234 |
Outcome results
Primary
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: 18 Months
Population: Participants not taking investigational drug were not included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole 15 mg QD | Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 6 participants |
| Gefarnate 50 mg BID | Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 53 participants |
p-value: <0.000195% CI: [0.0425, 0.23]Log Rank
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | -0.254 scores on a scale | Standard Deviation 0.766 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | 0.136 scores on a scale | Standard Deviation 0.409 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | -0.132 scores on a scale | Standard Deviation 0.552 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | 0.228 scores on a scale | Standard Deviation 0.755 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | -0.165 scores on a scale | Standard Deviation 0.583 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | 0.149 scores on a scale | Standard Deviation 0.741 |
p-value: 0.0006Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | -0.092 scores on a scale | Standard Deviation 0.542 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | 0.216 scores on a scale | Standard Deviation 0.688 |
p-value: 0.0025Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | -0.224 scores on a scale | Standard Deviation 1.112 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | 0.205 scores on a scale | Standard Deviation 1.047 |
p-value: 0.0433Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | -0.150 scores on a scale | Standard Deviation 0.904 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | 0.460 scores on a scale | Standard Deviation 1.241 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | -0.153 scores on a scale | Standard Deviation 1.172 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | 0.530 scores on a scale | Standard Deviation 1.444 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | -0.149 scores on a scale | Standard Deviation 1.157 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9) | 0.419 scores on a scale | Standard Deviation 1.375 |
p-value: 0.0079Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | 0.000 scores on a scale | Standard Deviation 0.204 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | -0.036 scores on a scale | Standard Deviation 0.189 |
p-value: 0.4484Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | -0.333 scores on a scale | Standard Deviation 0.577 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | NA scores on a scale | — |
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | 0.005 scores on a scale | Standard Deviation 0.254 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | 0.010 scores on a scale | Standard Deviation 0.175 |
p-value: 0.6175Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | -0.019 scores on a scale | Standard Deviation 0.177 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | 0.000 scores on a scale | Standard Deviation 0.246 |
p-value: 0.4496Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9) | -0.018 scores on a scale | Standard Deviation 0.19 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9) | 0.000 scores on a scale | Standard Deviation 0.153 |
p-value: 0.4718Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | -0.020 scores on a scale | Standard Deviation 0.143 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | -0.036 scores on a scale | Standard Deviation 0.331 |
p-value: 0.7619Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | NA scores on a scale |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | -0.020 scores on a scale | Standard Deviation 0.315 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | -0.005 scores on a scale | Standard Deviation 0.312 |
p-value: 0.8604Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | -0.019 scores on a scale | Standard Deviation 0.329 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | 0.015 scores on a scale | Standard Deviation 0.325 |
p-value: 0.5485Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9) | -0.027 scores on a scale | Standard Deviation 0.368 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9) | -0.023 scores on a scale | Standard Deviation 0.265 |
p-value: 0.7382Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | -0.163 scores on a scale | Standard Deviation 0.373 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | -0.036 scores on a scale | Standard Deviation 0.331 |
p-value: 0.145Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | NA scores on a scale |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | -0.064 scores on a scale | Standard Deviation 0.387 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | -0.005 scores on a scale | Standard Deviation 0.411 |
p-value: 0.2694Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | -0.089 scores on a scale | Standard Deviation 0.346 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | 0.038 scores on a scale | Standard Deviation 0.451 |
p-value: 0.0141Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9) | -0.063 scores on a scale | Standard Deviation 0.411 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9) | 0.000 scores on a scale | Standard Deviation 0.376 |
p-value: 0.3128Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | -0.082 scores on a scale | Standard Deviation 0.277 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | 0.000 scores on a scale | Standard Deviation 0 |
p-value: 0.1229Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | NA scores on a scale |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | -0.025 scores on a scale | Standard Deviation 0.233 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | 0.020 scores on a scale | Standard Deviation 0.142 |
p-value: 0.0204Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | -0.051 scores on a scale | Standard Deviation 0.22 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | 0.008 scores on a scale | Standard Deviation 0.087 |
p-value: 0.0046Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9) | -0.072 scores on a scale | Standard Deviation 0.26 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9) | 0.012 scores on a scale | Standard Deviation 0.108 |
p-value: 0.0059Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) | -0.020 scores on a scale | Standard Deviation 0.143 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) | 0.000 scores on a scale | Standard Deviation 0 |
p-value: 0.4497Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | NA scores on a scale |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) | -0.010 scores on a scale | Standard Deviation 0.099 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) | 0.020 scores on a scale | Standard Deviation 0.286 |
p-value: 0.2604Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) | -0.006 scores on a scale | Standard Deviation 0.138 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) | 0.000 scores on a scale | Standard Deviation 0.123 |
p-value: 0.6818Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9) | -0.009 scores on a scale | Standard Deviation 0.165 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9) | -0.012 scores on a scale | Standard Deviation 0.108 |
p-value: 0.9015Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | 0.000 scores on a scale | Standard Deviation 0.204 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | -0.071 scores on a scale | Standard Deviation 0.262 |
p-value: 0.1862Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | -0.333 scores on a scale | Standard Deviation 0.577 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | -1.000 scores on a scale | — |
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | 0.005 scores on a scale | Standard Deviation 0.307 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | 0.026 scores on a scale | Standard Deviation 0.357 |
p-value: 0.7054Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | -0.038 scores on a scale | Standard Deviation 0.192 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | -0.008 scores on a scale | Standard Deviation 0.261 |
p-value: 0.34Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9) | -0.027 scores on a scale | Standard Deviation 0.211 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9) | -0.023 scores on a scale | Standard Deviation 0.152 |
p-value: 0.8813Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 12.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | -0.020 scores on a scale | Standard Deviation 0.143 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | -0.071 scores on a scale | Standard Deviation 0.262 |
p-value: 0.2688Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | -0.333 scores on a scale | Standard Deviation 0.577 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | -1.000 scores on a scale | — |
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 3.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | -0.005 scores on a scale | Standard Deviation 0.187 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | 0.015 scores on a scale | Standard Deviation 0.295 |
p-value: 0.6148Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 6.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | -0.025 scores on a scale | Standard Deviation 0.158 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | -0.030 scores on a scale | Standard Deviation 0.171 |
p-value: 0.805Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 9.
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9) | -0.027 scores on a scale | Standard Deviation 0.163 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9) | -0.023 scores on a scale | Standard Deviation 0.152 |
p-value: 0.8678Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Adverse Events
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
Time frame: 18 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse event (Frequency ≥5%) | 82 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Serious adverse event | 27 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse event related to the study drug | 26 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Serious adverse event related to the study drug | 0 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse event | 166 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Serious adverse event related to the study drug | 1 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Adverse event | 168 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Adverse event (Frequency ≥5%) | 68 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Adverse event related to the study drug | 25 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Serious adverse event | 26 participants |
Secondary
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: 18 Months
Population: Values are from the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole 15 mg QD | Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 7 participants |
| Gefarnate 50 mg BID | Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 56 participants |
p-value: <0.0001Log Rank