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

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

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).

Study Overview

• Status: Completed
• Conditions: Duodenal Ulcer; Stomach Ulcer
• Intervention / Treatment: Drug: Lansoprazole; Drug: Gefarnate

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.

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Kasugai-shi, Aichi, Japan
  • Chiba
    • Yotsukaido-shi, Chiba, Japan
  • Ehime
    • Matsuyama-shi, Ehime, Japan
  • Fukui
    • Fukui-shi, Fukui, Japan
  • Fukuoka
    • Chikushi-gun, Fukuoka, Japan
    • Fukuoka-shi, Fukuoka, Japan
    • Kurume-shi, Fukuoka, Japan
    • Munakata-shi, Fukuoka, Japan
    • Onga-gun, Fukuoka, Japan
  • Gifu
    • Gifu-shi, Gifu, Japan
  • Gunma
    • Maebashi-shi, Gunma, Japan
  • Hiroshima
    • Higashihiroshima-shi, Hiroshima, Japan
    • Kure-shi, Hiroshima, Japan
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan
    • Chitose-shi, Hokkaido, Japan
    • Sapporo-shi, Hokkaido, Japan
  • Hyogo
    • Kato-shi, Hyogo, Japan
    • Nishinomiya-shi, Hyogo, Japan
  • Ibaraki
    • Hitachinaka-shi, Ibaraki, Japan
    • Yuki-shi, Ibaraki, Japan
  • Ishikawa
    • Hakusan-shi, Ishikawa, Japan
    • Komatsu-shi, Ishikawa, Japan
  • Kagawa
    • Takamatsu-shi, Kagawa, Japan
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan
    • Kawasaki-shi, Kanagawa, Japan
    • Sagamihara-shi, Kanagawa, Japan
    • Yamato-shi, Kanagawa, Japan
    • Yokohama-shi, Kanagawa, Japan
  • Kochi
    • Kochi-shi, Kochi, Japan
    • Susaki-shi, Kochi, Japan
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan
  • Kyoto
    • Kyoto-shi, Kyoto, Japan
  • Mie
    • Ise-shi, Mie, Japan
    • Shima-shi, Mie, Japan
    • Yokkaichi-shi, Mie, Japan
  • Miyagi
    • Sendai-shi, Miyagi, Japan
  • Miyazaki
    • Ebino-shi, Miyazaki, Japan
    • Miyazaki-gun, Miyazaki, Japan
    • Miyazaki-shi, Miyazaki, Japan
  • Nagano
    • Matsumoto-shi, Nagano, Japan
  • Nagasaki
    • Omura-shi, Nagasaki, Japan
  • Niigata
    • Niigata-shi, Niigata, Japan
  • Oita
    • Beppu-shi, Oita, Japan
  • Okayama
    • Okayama-shi, Okayama, Japan
  • Osaka
    • Daito-shi, Osaka, Japan
    • Osaka-shi, Osaka, Japan
    • Sakai-shi, Osaka, Japan
  • Saga
    • Ogi-shi, Saga, Japan
    • Saga-shi, Saga, Japan
  • Saitama
    • Hanyu-shi, Saitama, Japan
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan
  • Tochigi
    • Shimotsuke-shi, Tochigi, Japan
  • Tokushima
    • Naruto-shi, Tokushima, Japan
    • Tokushima-shi, Tokushima, Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan
    • Hachioji-shi, Tokyo, Japan
    • Kiyose-shi, Tokyo, Japan
    • Machida-shi, Tokyo, Japan
    • Meguro-ku, Tokyo, Japan
    • Nishitokyo-shi, Tokyo, Japan
    • Shibuya-ku, Tokyo, Japan
    • Shinjuku-ku, Tokyo, Japan
    • Toshima-ku, Tokyo, Japan
  • Tottori
    • Tottori-shi, Tottori, Japan
    • Yonago-shi, Tottori, Japan
  • Yamaguchi
    • Shimonoseki-shi, Yamaguchi, Japan
    • Yanai-shi, Yamaguchi, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lansoprazole 15 mg QD	Drug: Lansoprazole; Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.; Other Names: AG-1749
Active Comparator: Gefarnate 50 mg BID	Drug: Gefarnate; Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and 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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and 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.	On occurrence (up to month 24).
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Baseline and Month 3.
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.	Baseline and Month 6.
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.	Baseline and Month 12.
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.	Baseline and Month 18.
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.	Baseline and Month 24.
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.	Per Incidence (up to 24 months).

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Drug Therapy; Gastric Ulcer; Curling Ulcer; Nonsteroid anti-inflammatory drug
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Stomach Ulcer; Duodenal Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Gefarnate
• Other Study ID Numbers: AG-1749-CCT-352; 070495 (Registry Identifier: JapicCTI); U1111-1114-2071 (Registry Identifier: WHO); R100126 (Registry Identifier: JapicCTI)