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

Primary Purpose

Stomach Ulcer, Duodenal Ulcer

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lansoprazole
Gefarnate
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Ulcer focused on measuring Curling Ulcer, Gastric Ulcer, Aspirin, Acetylsalicylic Acid, Drug Therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lansoprazole 15 mg QD

Gefarnate 50 mg BID

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 26, 2008
Last Updated
February 1, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT00762359
Brief Title
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Official Title
A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric And Duodenal Ulcers During Long-Term Treatment With Low Dose Aspirin.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
AG-1749 superior to Gefarnate in ulcer prevention
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer, Duodenal Ulcer
Keywords
Curling Ulcer, Gastric Ulcer, Aspirin, Acetylsalicylic Acid, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lansoprazole 15 mg QD
Arm Type
Experimental
Arm Title
Gefarnate 50 mg BID
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
AG-1749, PREVACID®, Takepron®
Intervention Description
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
Intervention Type
Drug
Intervention Name(s)
Gefarnate
Intervention Description
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Primary Outcome Measure Information:
Title
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
Description
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and <1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves >6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect < 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Description
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and < 1 lesion; 2= 2 to 5 lesions ; 3= > 6 lesions). Erosions are defined as mucosal defect < 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Time Frame
Baseline and Month 18.
Title
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
Description
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Time Frame
18 Months
Title
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
Description
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
Description
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)
Description
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
Description
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
Description
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
Description
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
Description
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)
Description
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
Description
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
Description
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
Description
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
Description
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)
Description
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
Description
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
Description
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
Description
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
Description
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
Description
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
Description
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
Description
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
Description
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
Description
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)
Description
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
Description
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
Description
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
Description
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
Description
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
Description
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
Description
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
Description
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
Description
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 3.
Title
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
Description
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 6.
Title
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)
Description
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 9.
Title
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
Description
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 12.
Title
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
Description
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Time Frame
Baseline and Month 18.
Title
Number of Participants With Adverse Events
Description
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
Time Frame
18 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Matsudo-shi
State/Province
Chiba
Country
Japan
City
Yotsukaido-shi
State/Province
Chiba
Country
Japan
City
Imabari-shi
State/Province
Ehime
Country
Japan
City
Matsuyama-shi
State/Province
Ehime
Country
Japan
City
Fukui-shi
State/Province
Fukui
Country
Japan
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
City
Onga-gun
State/Province
Fukuoka
Country
Japan
City
Gifu-shi
State/Province
Gifu
Country
Japan
City
Fujioka-shi
State/Province
Gunma
Country
Japan
City
Maebashi-shi
State/Province
Gunma
Country
Japan
City
Higashihiroshima-shi
State/Province
Hiroshima
Country
Japan
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
City
Kure-shi
State/Province
Hiroshima
Country
Japan
City
Asahikawa-shi
State/Province
Hokkaido
Country
Japan
City
Hakodate-shi
State/Province
Hokkaido
Country
Japan
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
City
Nishinomiya-shi
State/Province
Hyogo
Country
Japan
City
Higashiibaraki-gun
State/Province
Ibaraki
Country
Japan
City
Hitachinaka-shi
State/Province
Ibaraki
Country
Japan
City
Inashiki-gun
State/Province
Ibaraki
Country
Japan
City
Namegata-shi
State/Province
Ibaraki
Country
Japan
City
Tsuchiura-shi
State/Province
Ibaraki
Country
Japan
City
Yuuki-shi
State/Province
Ibaraki
Country
Japan
City
Hakusan-shi
State/Province
Ishikawa
Country
Japan
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
City
Komatsu-shi
State/Province
Ishikawa
Country
Japan
City
Takamatsu-shi
State/Province
Kagawa
Country
Japan
City
Fujisawa-shi
State/Province
Kanagawa
Country
Japan
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
City
Yamato-shi
State/Province
Kanagawa
Country
Japan
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
City
Yokosuka-shi
State/Province
Kanagawa
Country
Japan
City
Kochi-shi
State/Province
Kochi
Country
Japan
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
City
Matsusaka-shi
State/Province
Mie
Country
Japan
City
Shima-shi
State/Province
Mie
Country
Japan
City
Tsu-shi
State/Province
Mie
Country
Japan
City
Sendai-shi
State/Province
Miyagi
Country
Japan
City
Ebino-shi
State/Province
Miyazaki
Country
Japan
City
Miyazaki-shi
State/Province
Miyazaki
Country
Japan
City
Joetsu-shi
State/Province
Niigata
Country
Japan
City
Niigata-shi
State/Province
Niigata
Country
Japan
City
Beppu-shi
State/Province
Ooita
Country
Japan
City
Ooita-shi
State/Province
Ooita
Country
Japan
City
Ibaraki-shi
State/Province
Osaka
Country
Japan
City
Matsubara-shi
State/Province
Osaka
Country
Japan
City
Osaka-shi
State/Province
Osaka
Country
Japan
City
Takatsuki-shi
State/Province
Osaka
Country
Japan
City
Hanyuu-shi
State/Province
Saitama
Country
Japan
City
Ootsu-shi
State/Province
Shiga
Country
Japan
City
Hamada-shi
State/Province
Shimane
Country
Japan
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
City
Shimotsuke-shi
State/Province
Tochigi
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
City
Chuuo-ku
State/Province
Tokyo
Country
Japan
City
Hachioji-shi
State/Province
Tokyo
Country
Japan
City
Kiyose-shi
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Toshima-ku
State/Province
Tokyo
Country
Japan
City
Higashitagawa-gun
State/Province
Yamagata
Country
Japan
City
Iwakuni-shi
State/Province
Yamaguchi
Country
Japan
City
Shimonoseki-shi
State/Province
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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