Efficacy and Safety of AG-1749 on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

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 nonsteroid anti-inflammatory drug.

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

Primary outcome: Rate of onset 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, 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.

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

Criteria:

Inclusion Criteria:

- Is on nonsteroid anti-inflammatory drug 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.

- 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.

- Has serious cardiac dysfunction, hyperpiesia, blood disorder.

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

Kasugai-shi, Aichi, Japan; Recruiting

Yotsukaido-shi, Chiba, Japan; Recruiting

Matsuyama-shi, Ehime, Japan; Recruiting

Fukui-shi, Fukui, Japan; Recruiting

Munakata-shi, Fukuoka, Japan; Recruiting

Onga-gun, Fukuoka, Japan; Recruiting

Kurume-shi, Fukuoka, Japan; Recruiting

Fukuoka-shi, Fukuoka, Japan; Recruiting

Chikushi-gun, Fukuoka, Japan; Recruiting

Gifu-shi, Gifu, Japan; Recruiting

Maebashi-shi, Gunma, Japan; Recruiting

Higashihiroshima-shi, Hiroshima, Japan; Recruiting

Kure-shi, Hiroshima, Japan; Recruiting

Sapporo-shi, Hokkaido, Japan; Recruiting

Chitose-shi, Hokkaido, Japan; Recruiting

Asahikawa-shi, Hokkaido, Japan; Recruiting

Nishinomiya-shi, Hyogo, Japan; Recruiting

Kato-shi, Hyogo, Japan; Recruiting

Hitachinaka-shi, Ibaraki, Japan; Recruiting

Yuki-shi, Ibaraki, Japan; Recruiting

Komatsu-shi, Ishikawa, Japan; Recruiting

Hakusan-shi, Ishikawa, Japan; Recruiting

Takamatsu-shi, Kagawa, Japan; Recruiting

Kagoshima-shi, Kagoshima, Japan; Recruiting

Kamakura-shi, Kanagawa, Japan; Recruiting

Kawasaki-shi, Kanagawa, Japan; Recruiting

Yokohama-shi, Kanagawa, Japan; Recruiting

Sagamihara-shi, Kanagawa, Japan; Recruiting

Yamato-shi, Kanagawa, Japan; Recruiting

Kochi-shi, Kochi, Japan; Recruiting

Susaki-shi, Kochi, Japan; Recruiting

Kumamoto-shi, Kumamoto, Japan; Recruiting

Kyoto-shi, Kyoto, Japan; Recruiting

Yokkaichi-shi, Mie, Japan; Recruiting

Ise-shi, Mie, Japan; Recruiting

Shima-shi, Mie, Japan; Recruiting

Sendai-shi, Miyagi, Japan; Recruiting

Ebino-shi, Miyazaki, Japan; Recruiting

Miyazaki-shi, Miyazaki, Japan; Recruiting

Miyazaki-gun, Miyazaki, Japan; Recruiting

Matsumoto-shi, Nagano, Japan; Recruiting

Omura-shi, Nagasaki, Japan; Recruiting

Niigata-shi, Niigata, Japan; Recruiting

Beppu-shi, Oita, Japan; Recruiting

Okayama-shi, Okayama, Japan; Recruiting

Osaka-shi, Osaka, Japan; Recruiting

Sakai-shi, Osaka, Japan; Recruiting

Daito-shi, Osaka, Japan; Recruiting

Ogi-shi, Saga, Japan; Recruiting

Saga-shi, Saga, Japan; Recruiting

Hanyu-shi, Saitama, Japan; Recruiting

Sunto-gun, Shizuoka, Japan; Recruiting

Shimotsuke-shi, Tochigi, Japan; Recruiting

Naruto-shi, Tokushima, Japan; Recruiting

Tokushima-shi, Tokushima, Japan; Recruiting

Shinjuku-ku, Tokyo, Japan; Recruiting

Toshima-ku, Tokyo, Japan; Recruiting

Meguro-ku, Tokyo, Japan; Recruiting

Shibuya-ku, Tokyo, Japan; Recruiting

Chuo-ku, Tokyo, Japan; Recruiting

Hachioji-shi, Tokyo, Japan; Recruiting

Kiyose-shi, Tokyo, Japan; Recruiting

Nishitokyo-shi, Tokyo, Japan; Recruiting

Machida-shi, Tokyo, Japan; Recruiting

Tottori-shi, Tottori, Japan; Recruiting

Yonago-shi, Tottori, Japan; Recruiting

Yanai-shi, Yamaguchi, Japan; Recruiting

Shimonoseki-shi, Yamaguchi, Japan; Recruiting

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Last updated: November 6, 2008