Duodenal Ulcer, Stomach Ulcer
Conditions
Keywords
Curling Ulcer, Gastric Ulcer, Nonsteroid anti-inflammatory drug, Drug Therapy
Brief summary
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).
Detailed description
In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of 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 nonsteroid anti-inflammatory medication.
Interventions
DRUGLansoprazole
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
DRUGGefarnate
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 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 nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs. * Past or planned surgery affecting gastric acid secretion. * Clinically significant hepatic or renal disorder. * Serious cardiac dysfunction, hypertension, or hematological disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 24 Months | The number of participants that developed gastric ulcer and/or duodenal ulcer at month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. |
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 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 Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | Baseline and Month 24. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury. |
| 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 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. |
| Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | Baseline and Month 24. | The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | On occurrence (up to month 24). | Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | Baseline and Month 3. | The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | Baseline and Month 6. | The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| 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. | The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12) | Baseline and Month 12. | The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | Baseline and Month 18. | The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24) | Baseline and Month 24. | The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
| Number of Participants With Adverse Events | Per Incidence (up to 24 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. | The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom. |
Countries
Japan
Participant flow
Recruitment details
Participants were enrolled at sites in Japan from April 2007 to May 2009.
Pre-assignment details
Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups. NSAID = Nonsteroidal anti-inflammatory drug.
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 6 to 24 months. | 185 |
| Gefarnate 50 mg BID Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months. | 181 |
| Total | 366 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 24 | 23 |
| Overall Study | Institution closed | 1 | 0 |
| Overall Study | Lack of Efficacy | 4 | 15 |
| Overall Study | NSAIDs discontinuation | 1 | 2 |
| Overall Study | Physician Decision | 4 | 8 |
| Overall Study | Protocol Violation | 26 | 23 |
| Overall Study | Withdrawal by Subject | 16 | 11 |
Baseline characteristics
| Characteristic | Total | Gefarnate 50 mg BID | Lansoprazole 15 mg QD |
|---|---|---|---|
| Age, Customized ≤39 years | 13 participants 3.6 | 6 participants 3.3 | 7 participants 3.8 |
| Age, Customized ≤80 years | 25 participants 6.8 | 12 participants 6.6 | 13 participants 7 |
| Age, Customized Between 40 and 49 years | 31 participants 8.5 | 13 participants 7.2 | 18 participants 9.7 |
| Age, Customized Between 50 and 59 years | 81 participants 22.1 | 43 participants 23.8 | 38 participants 20.5 |
| Age, Customized Between 60 and 64 years | 62 participants 16.9 | 29 participants 16 | 33 participants 17.8 |
| Age, Customized Between 65 and 69 years | 63 participants 17.2 | 30 participants 16.6 | 33 participants 17.8 |
| Age, Customized Between 70 and 79 years | 91 participants 24.9 | 48 participants 26.5 | 43 participants 23.2 |
| Region of Enrollment Japan | 366 participants | 181 participants | 185 participants |
| Sex: Female, Male Female | 219 Participants | 107 Participants | 112 Participants |
| Sex: Female, Male Male | 147 Participants | 74 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 183 | 64 / 181 |
| serious Total, serious adverse events | 29 / 183 | 17 / 181 |
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 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: 24 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 | 15 participants |
| Gefarnate 50 mg BID | Number of Participants With Gastric Ulcer and/or Duodenal Ulcer | 46 participants |
p-value: <0.000195% CI: [0.14, 0.4499]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) | -0.177 scores on a scale | Standard Deviation 0.675 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | 0.048 scores on a scale | Standard Deviation 0.381 |
p-value: 0.0068Wilcoxon (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: 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 18) | -0.297 scores on a scale | Standard Deviation 0.812 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | -0.056 scores on a scale | Standard Deviation 0.539 |
p-value: 0.2363Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time frame: Baseline and Month 24.
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 Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | -0.200 scores on a scale | Standard Deviation 0.447 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | NA scores on a scale | — |
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) | -0.102 scores on a scale | Standard Deviation 0.499 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | 0.142 scores on a scale | Standard Deviation 0.649 |
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) | -0.095 scores on a scale | Standard Deviation 0.527 |
| Gefarnate 50 mg BID | Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | 0.047 scores on a scale | Standard Deviation 0.373 |
p-value: 0.0161Wilcoxon (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) | -0.231 scores on a scale | Standard Deviation 1.299 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12) | 0.048 scores on a scale | Standard Deviation 1.137 |
p-value: 0.0652Wilcoxon (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: 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 18) | -0.162 scores on a scale | Standard Deviation 1.28 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18) | -0.278 scores on a scale | Standard Deviation 1.227 |
p-value: 0.9836Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time frame: Baseline and Month 24.
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 Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | -0.800 scores on a scale | Standard Deviation 1.304 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24) | NA scores on a scale | — |
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) | -0.114 scores on a scale | Standard Deviation 1.02 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3) | 0.429 scores on a scale | Standard Deviation 1.318 |
p-value: 0.0002Wilcoxon (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 (MEAN) | Dispersion |
|---|---|---|---|
| Lansoprazole 15 mg QD | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | -0.319 scores on a scale | Standard Deviation 1.06 |
| Gefarnate 50 mg BID | Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6) | 0.188 scores on a scale | Standard Deviation 1.268 |
p-value: 0.0041Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
The number of participants that develop anorexia at month 12, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.014 scores on a scale | Standard Deviation 0.208 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12) | -0.020 scores on a scale | Standard Deviation 0.143 |
p-value: 0.3117Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
The number of participants that develop anorexia at month 18, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | 0.056 scores on a scale | Standard Deviation 0.236 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18) | 0.000 scores on a scale | Standard Deviation 0 |
p-value: 0.4344t-test, 2 sided
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)
The number of participants that develop anorexia at month 24, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 Anorexia Gastrointestinal Symptom (Month 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
The number of participants that develop anorexia at month 3, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.006 scores on a scale | Standard Deviation 0.138 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3) | 0.022 scores on a scale | Standard Deviation 0.283 |
p-value: 0.5328Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
The number of participants that develop anorexia at month 6, and number of participants that develop anorexia at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.036 scores on a scale | Standard Deviation 0.187 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6) | 0.024 scores on a scale | Standard Deviation 0.268 |
p-value: 0.7223Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of an enlarged abdomen at month 12, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.057 scores on a scale | Standard Deviation 0.336 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12) | -0.204 scores on a scale | Standard Deviation 0.407 |
p-value: 0.0355Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of an enlarged abdomen at month 18, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | -0.056 scores on a scale | Standard Deviation 0.416 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18) | 0.000 scores on a scale | Standard Deviation 0.447 |
p-value: 0.7325Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of an enlarged abdomen at month 24, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of an enlarged abdomen at month 3, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.025 scores on a scale | Standard Deviation 0.318 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3) | -0.014 scores on a scale | Standard Deviation 0.452 |
p-value: 0.698Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of an enlarged abdomen at month 6, and number of participants that develop the feeling of an enlarged abdomen at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.000 scores on a scale | Standard Deviation 0.381 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6) | -0.048 scores on a scale | Standard Deviation 0.408 |
p-value: 0.4599Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of heartburn at month 12, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.114 scores on a scale | Standard Deviation 0.363 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12) | -0.102 scores on a scale | Standard Deviation 0.51 |
p-value: 0.7121Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of heartburn at month 18, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | -0.056 scores on a scale | Standard Deviation 0.236 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18) | 0.091 scores on a scale | Standard Deviation 0.302 |
p-value: 0.1522Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of heartburn at month 24, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 24) | -1.000 scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of heartburn at month 3, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.057 scores on a scale | Standard Deviation 0.378 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3) | 0.058 scores on a scale | Standard Deviation 0.625 |
p-value: 0.0703Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of heartburn at month 6, and number of participants that develop the feeling of heartburn at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.027 scores on a scale | Standard Deviation 0.476 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6) | -0.095 scores on a scale | Standard Deviation 0.428 |
p-value: 0.3046Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
The number of participants that develop the feeling of nausea at month 12, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.043 scores on a scale | Standard Deviation 0.204 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12) | -0.041 scores on a scale | Standard Deviation 0.2 |
p-value: 0.9566Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
The number of participants that develop the feeling of nausea at month 18, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | 0.000 scores on a scale | Standard Deviation 0 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18) | -0.091 scores on a scale | Standard Deviation 0.302 |
p-value: 0.2008Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)
The number of participants that develop the feeling of nausea at month 24, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
The number of participants that develop the feeling of nausea at month 3, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.006 scores on a scale | Standard Deviation 0.239 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3) | 0.007 scores on a scale | Standard Deviation 0.308 |
p-value: 0.8262Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
The number of participants that develop the feeling of nausea at month 6, and number of participants that develop the feeling of nausea at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.009 scores on a scale | Standard Deviation 0.286 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6) | -0.012 scores on a scale | Standard Deviation 0.245 |
p-value: 0.7244Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 12, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.043 scores on a scale | Standard Deviation 0.359 |
| 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: 0.4028Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 18, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | 0.000 scores on a scale | Standard Deviation 0 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18) | 0.000 scores on a scale | Standard Deviation 0 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 24, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 3, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.006 scores on a scale | Standard Deviation 0.08 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3) | -0.007 scores on a scale | Standard Deviation 0.085 |
p-value: 0.1571Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
The number of participants that experience hematemesis and melena (blood stool, black stool, tarry stool) at month 6, and number of participants that experience hematemesis and melena at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.000 scores on a scale | Standard Deviation 0 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6) | 0.012 scores on a scale | Standard Deviation 0.109 |
p-value: 0.2503Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop hunger and nighttime pain at month 12, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.029 scores on a scale | Standard Deviation 0.416 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12) | -0.061 scores on a scale | Standard Deviation 0.317 |
p-value: 0.7794Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop hunger and nighttime pain at month 18, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | 0.000 scores on a scale | Standard Deviation 0 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18) | 0.000 scores on a scale | Standard Deviation 0.447 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop hunger and nighttime pain at month 24, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop hunger and nighttime pain at month 3, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.044 scores on a scale | Standard Deviation 0.326 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3) | 0.014 scores on a scale | Standard Deviation 0.4 |
p-value: 0.206Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop hunger and nighttime pain at month 6, and number of participants that develop hunger and nighttime pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.009 scores on a scale | Standard Deviation 0.393 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6) | -0.036 scores on a scale | Standard Deviation 0.424 |
p-value: 0.5099Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
The number of participants that develop postprandial pain at month 12, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.014 scores on a scale | Standard Deviation 0.208 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12) | -0.020 scores on a scale | Standard Deviation 0.249 |
p-value: 0.8811Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
The number of participants that develop postprandial pain at month 18, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 18.
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 18) | 0.000 scores on a scale | Standard Deviation 0 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18) | 0.000 scores on a scale | Standard Deviation 0 |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)
The number of participants that develop postprandial pain at month 24, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time frame: Baseline and Month 24.
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 Postprandial Pain Gastrointestinal Symptom (Month 24) | NA scores on a scale |
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
The number of participants that develop postprandial pain at month 3, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | -0.006 scores on a scale | Standard Deviation 0.178 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3) | 0.014 scores on a scale | Standard Deviation 0.319 |
p-value: 0.4788Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
The number of participants that develop postprandial pain at month 6, and number of participants that develop postprandial pain at baseline. It is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
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) | 0.027 scores on a scale | Standard Deviation 0.285 |
| Gefarnate 50 mg BID | Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6) | 0.000 scores on a scale | Standard Deviation 0.347 |
p-value: 0.6607Wilcoxon (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: Per Incidence (up to 24 months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse event (Frequency ≥5%) | 83 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Serious adverse event | 29 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse event related to the study drug | 28 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Serious adverse event related to the study drug | 2 participants |
| Lansoprazole 15 mg QD | Number of Participants With Adverse Events | Adverse Event | 154 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 | 125 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Adverse event (Frequency ≥5%) | 64 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Adverse event related to the study drug | 28 participants |
| Gefarnate 50 mg BID | Number of Participants With Adverse Events | Serious adverse event | 17 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 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time frame: On occurrence (up to month 24).
Population: On days where participants did not have an occurrence of gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) and who also underwent endoscopic examination were considered censored dates. Values are from the Full Analysis Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lansoprazole 15 mg QD | Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 15 participants |
| Gefarnate 50 mg BID | Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage) | 52 participants |
p-value: <0.0001Log Rank