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

Condition(s) targeted: Stomach Ulcer; Duodenal Ulcer

Intervention: lansoprazole (Drug); gefarnate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Takeda Pharmaceutical Company Ltd.

Official(s) and/or principal investigator(s):
General Manager, Study Director, Affiliation: Takeda Pharmaceutical Company Ltd.

Overall contact:
Senior Manager, Phone: +81-6-6204-2111

The purpose of this study is to determine whether lansoprazole is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rate of recurrence of gastric ulcer and/or duodenal ulcer.

Secondary outcome:

Rate of onset of gastric and duodenal mucosal injury, hemorrhagic lesions and gastrointestinal symptoms.

Adverse events.

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Is 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.

- Is confirmed to have a history of gastric ulcer or duodenal ulcer (combined gastric

and duodenal ulcer is also possible).

Exclusion Criteria:

- Has gastric and/or duodenal ulcer just before study drug administration.

- The patient has active upper gastrointestinal bleeding just before study drug

administration.

- Has aspirin-induced asthma, hypersensitivity towards nonsteroidal anti-inflammatory

drugs or a history of it.

- Has undergone or is scheduled to undergo surgery that will affect gastric secretion.

- Has clinically apparent liver or kidney disorder.

Senior Manager, Phone: +81-6-6204-2111

Matsudo-shi, Chiba, Japan; Recruiting

Yotsukaido-shi, Chiba, Japan; Recruiting

Imabari-shi, Ehime, Japan; Recruiting

Matsuyama-shi, Ehime, Japan; Recruiting

Fukui-shi, Fukui, Japan; Recruiting

Fukuoka-shi, Fukuoka, Japan; Recruiting

Onga-gun, Fukuoka, Japan; Recruiting

Gifu-shi, Gifu, Japan; Recruiting

Fujioka-shi, Gunma, Japan; Recruiting

Maebashi-shi, Gunma, Japan; Recruiting

Higashihiroshima-shi, Hiroshima, Japan; Recruiting

Hiroshima-shi, Hiroshima, Japan; Recruiting

Kure-shi, Hiroshima, Japan; Recruiting

Asahikawa-shi, Hokkaido, Japan; Recruiting

Hakodate-shi, Hokkaido, Japan; Recruiting

Sapporo-shi, Hokkaido, Japan; Recruiting

Nishinomiya-shi, Hyogo, Japan; Recruiting

Higashiibaraki-gun, Ibaraki, Japan; Recruiting

Hitachinaka-shi, Ibaraki, Japan; Recruiting

Inashiki-gun, Ibaraki, Japan; Recruiting

Namegata-shi, Ibaraki, Japan; Recruiting

Tsuchiura-shi, Ibaraki, Japan; Recruiting

Yuuki-shi, Ibaraki, Japan; Recruiting

Hakusan-shi, Ishikawa, Japan; Recruiting

Kanazawa-shi, Ishikawa, Japan; Recruiting

Komatsu-shi, Ishikawa, Japan; Recruiting

Takamatsu-shi, Kagawa, Japan; Recruiting

Fujisawa-shi, Kanagawa, Japan; Recruiting

Kawasaki-shi, Kanagawa, Japan; Recruiting

Yamato-shi, Kanagawa, Japan; Recruiting

Yokohama-shi, Kanagawa, Japan; Recruiting

Yokosuka-shi, Kanagawa, Japan; Recruiting

Kochi-shi, Kochi, Japan; Recruiting

Kumamoto-shi, Kumamoto, Japan; Recruiting

Kyoto-shi, Kyoto, Japan; Recruiting

Matsusaka-shi, Mie, Japan; Recruiting

Shima-shi, Mie, Japan; Recruiting

Tsu-shi, Mie, Japan; Recruiting

Sendai-shi, Miyagi, Japan; Recruiting

Ebino-shi, Miyazaki, Japan; Recruiting

Miyazaki-shi, Miyazaki, Japan; Recruiting

Joetsu-shi, Niigata, Japan; Recruiting

Niigata-shi, Niigata, Japan; Recruiting

Beppu-shi, Ooita, Japan; Recruiting

Ooita-shi, Ooita, Japan; Recruiting

Ibaraki-shi, Osaka, Japan; Recruiting

Matsubara-shi, Osaka, Japan; Recruiting

Osaka-shi, Osaka, Japan; Recruiting

Takatsuki-shi, Osaka, Japan; Recruiting

Hanyuu-shi, Saitama, Japan; Recruiting

Ootsu-shi, Shiga, Japan; Recruiting

Hamada-shi, Shimane, Japan; Recruiting

Sunto-gun, Shizuoka, Japan; Recruiting

Shimotsuke-shi, Tochigi, Japan; Recruiting

Chiyoda-ku, Tokyo, Japan; Recruiting

Chuuo-ku, Tokyo, Japan; Recruiting

Hachioji-shi, Tokyo, Japan; Recruiting

Kiyose-shi, Tokyo, Japan; Recruiting

Minato-ku, Tokyo, Japan; Recruiting

Shinagawa-ku, Tokyo, Japan; Recruiting

Shinjuku-ku, Tokyo, Japan; Recruiting

Toshima-ku, Tokyo, Japan; Recruiting

Higashitagawa-gun, Yamagata, Japan; Recruiting

Iwakuni-shi, Yamaguchi, Japan; Recruiting

Shimonoseki-shi, Yamaguchi, Japan; Recruiting

PREVACID® Package Insert

Starting date: May 2007
Ending date: December 2009
Last updated: September 29, 2008