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

NCT ID: NCT00762359

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 461 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-11-30

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.

Conditions

Stomach Ulcer; Duodenal Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lansoprazole 15 mg QD

Group Type: EXPERIMENTAL

Lansoprazole

Intervention Type: DRUG

Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.

Gefarnate 50 mg BID

Group Type: ACTIVE_COMPARATOR

Gefarnate

Intervention Type: DRUG

Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Interventions

Lansoprazole

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

Gefarnate

Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.

Intervention Type: DRUG

Other Intervention Names

AG-1749; PREVACID®; Takepron®

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Takeda

Locations

Matsudo-shi, Chiba, Japan

Yotsukaido-shi, Chiba, Japan

Imabari, Ehime, Japan

Matsuyama, Ehime, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Gifu, Gifu, Japan

Fujioka-shi, Gunma, Japan

Maebashi, Gunma, Japan

Higashihiroshima-shi, Hiroshima, Japan

Hiroshima, Hiroshima, Japan

Kure-shi, Hiroshima, Japan

Asahikawa-shi, Hokkaido, Japan

Hakodate-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Nishinomiya-shi, Hyōgo, Japan

Higashiibaraki-gun, Ibaraki, Japan

Hitachi-Naka, Ibaraki, Japan

Inashiki-gun, Ibaraki, Japan

Namegata-shi, Ibaraki, Japan

Tsuchiura-shi, Ibaraki, Japan

Yuuki-shi, Ibaraki, Japan

Hakusan-shi, Ishikawa-ken, Japan

Kanazawa, Ishikawa-ken, Japan

Komatsu-shi, Ishikawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Fujisawa-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Yamato-shi, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka-shi, Kanagawa, Japan

Kochi, Kochi, Japan

Kumamoto, Kumamoto, Japan

Kyoto, Kyoto, Japan

Matsusaka-shi, Mie-ken, Japan

Shima-shi, Mie-ken, Japan

Tsu, Mie-ken, Japan

Sendai, Miyagi, Japan

Ebino-shi, Miyazaki, Japan

Miyazaki, Miyazaki, Japan

Jōetsu, Niigata, Japan

Niigata, Niigata, Japan

Beppu-shi, Ooita, Japan

Ōita, Ooita, Japan

Ibaraki-shi, Osaka, Japan

Matsubara-shi, Osaka, Japan

Osaka, Osaka, Japan

Takatsuki-shi, Osaka, Japan

Hanyuu-shi, Saitama, Japan

Ōtsu, Shiga, Japan

Hamada-shi, Shimane, Japan

Sunto-gun, Shizuoka, Japan

Shimotsuke-shi, Tochigi, Japan

Chiyoda-ku, Tokyo, Japan

Chuuo-ku, Tokyo, Japan

Hachioji-shi, Tokyo, Japan

Kiyose-shi, Tokyo, Japan

Minato-ku, Tokyo, Japan

Shinagawa-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Toshima-ku, Tokyo, Japan

Higashitagawa-gun, Yamagata, Japan

Iwakuni-shi, Yamaguchi, Japan

Shimonoseki-shi, Yamaguchi, Japan

Countries

Japan

Other Identifiers

070494

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1113-9929

Identifier Type: REGISTRY

Identifier Source: secondary_id

R100125

Identifier Type: REGISTRY

Identifier Source: secondary_id

AG-1749-CCT-351

Identifier Type: -

Identifier Source: org_study_id