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

Primary Purpose

Stomach Ulcer, Duodenal Ulcer

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Lansoprazole

Gefarnate

About this trial

This is an interventional treatment trial for Stomach Ulcer focused on measuring Curling Ulcer, Gastric Ulcer, Nonsteroid anti-inflammatory drug, Drug Therapy

Eligibility Criteria

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

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.

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 24 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)

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

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)

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

NCT ID

NCT00787254

First Posted

November 6, 2008

Last Updated

February 1, 2012

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT00787254

Brief Title

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

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 Nonsteroid Anti-inflammatory Drug

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (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 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.

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, Nonsteroid anti-inflammatory drug, Drug Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

366 (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

Intervention Description

Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 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 6 to 24 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 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.

Time Frame

24 Months

Secondary Outcome Measure Information:

Title

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)

Description

Time Frame

On occurrence (up to month 24).

Title

Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)

Description

Time Frame

Baseline and Month 3.

Title

Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)

Description

Time Frame

Baseline and Month 6.

Title

Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)

Description

Time Frame

Baseline and Month 12.

Title

Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)

Description

Time Frame

Baseline and Month 18.

Title

Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 24)

Description

Time Frame

Baseline and Month 24.

Title

Number of Participants With Adverse Events

Description

Time Frame

Per Incidence (up to 24 months).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

General Manager

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Kasugai-shi

State/Province

Aichi

Country

Japan

City

Yotsukaido-shi

State/Province

Chiba

Country

Japan

City

Matsuyama-shi

State/Province

Ehime

Country

Japan

City

Fukui-shi

State/Province

Fukui

Country

Japan

City

Chikushi-gun

State/Province

Fukuoka

Country

Japan

City

Fukuoka-shi

State/Province

Fukuoka

Country

Japan

City

Kurume-shi

State/Province

Fukuoka

Country

Japan

City

Munakata-shi

State/Province

Fukuoka

Country

Japan

City

Onga-gun

State/Province

Fukuoka

Country

Japan

City

Gifu-shi

State/Province

Gifu

Country

Japan

City

Maebashi-shi

State/Province

Gunma

Country

Japan

City

Higashihiroshima-shi

State/Province

Hiroshima

Country

Japan

City

Kure-shi

State/Province

Hiroshima

Country

Japan

City

Asahikawa-shi

State/Province

Hokkaido

Country

Japan

City

Chitose-shi

State/Province

Hokkaido

Country

Japan

City

Sapporo-shi

State/Province

Hokkaido

Country

Japan

City

Kato-shi

State/Province

Hyogo

Country

Japan

City

Nishinomiya-shi

State/Province

Hyogo

Country

Japan

City

Hitachinaka-shi

State/Province

Ibaraki

Country

Japan

City

Yuki-shi

State/Province

Ibaraki

Country

Japan

City

Hakusan-shi

State/Province

Ishikawa

Country

Japan

City

Komatsu-shi

State/Province

Ishikawa

Country

Japan

City

Takamatsu-shi

State/Province

Kagawa

Country

Japan

City

Kagoshima-shi

State/Province

Kagoshima

Country

Japan

City

Kamakura-shi

State/Province

Kanagawa

Country

Japan

City

Kawasaki-shi

State/Province

Kanagawa

Country

Japan

City

Sagamihara-shi

State/Province

Kanagawa

Country

Japan

City

Yamato-shi

State/Province

Kanagawa

Country

Japan

City

Yokohama-shi

State/Province

Kanagawa

Country

Japan

City

Kochi-shi

State/Province

Kochi

Country

Japan

City

Susaki-shi

State/Province

Kochi

Country

Japan

City

Kumamoto-shi

State/Province

Kumamoto

Country

Japan

City

Kyoto-shi

State/Province

Kyoto

Country

Japan

City

Ise-shi

State/Province

Mie

Country

Japan

City

Shima-shi

State/Province

Mie

Country

Japan

City

Yokkaichi-shi

State/Province

Mie

Country

Japan

City

Sendai-shi

State/Province

Miyagi

Country

Japan

City

Ebino-shi

State/Province

Miyazaki

Country

Japan

City

Miyazaki-gun

State/Province

Miyazaki

Country

Japan

City

Miyazaki-shi

State/Province

Miyazaki

Country

Japan

City

Matsumoto-shi

State/Province

Nagano

Country

Japan

City

Omura-shi

State/Province

Nagasaki

Country

Japan

City

Niigata-shi

State/Province

Niigata

Country

Japan

City

Beppu-shi

State/Province

Oita

Country

Japan

City

Okayama-shi

State/Province

Okayama

Country

Japan

City

Daito-shi

State/Province

Osaka

Country

Japan

City

Osaka-shi

State/Province

Osaka

Country

Japan

City

Sakai-shi

State/Province

Osaka

Country

Japan

City

Ogi-shi

State/Province

Saga

Country

Japan

City

Saga-shi

State/Province

Saga

Country

Japan

City

Hanyu-shi

State/Province

Saitama

Country

Japan

City

Sunto-gun

State/Province

Shizuoka

Country

Japan

City

Shimotsuke-shi

State/Province

Tochigi

Country

Japan

City

Naruto-shi

State/Province

Tokushima

Country

Japan

City

Tokushima-shi

State/Province

Tokushima

Country

Japan

City

Chuo-ku

State/Province

Tokyo

Country

Japan

City

Hachioji-shi

State/Province

Tokyo

Country

Japan

City

Kiyose-shi

State/Province

Tokyo

Country

Japan

City

Machida-shi

State/Province

Tokyo

Country

Japan

City

Meguro-ku

State/Province

Tokyo

Country

Japan

City

Nishitokyo-shi

State/Province

Tokyo

Country

Japan

City

Shibuya-ku

State/Province

Tokyo

Country

Japan

City

Shinjuku-ku

State/Province

Tokyo

Country

Japan

City

Toshima-ku

State/Province

Tokyo

Country

Japan

City

Tottori-shi

State/Province

Tottori

Country

Japan

City

Yonago-shi

State/Province

Tottori

Country

Japan

City

Shimonoseki-shi

State/Province

Yamaguchi

Country

Japan

City

Yanai-shi

State/Province

Yamaguchi

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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