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Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Ulcers; Duodenal Ulcers

Intervention: TAK-438 (Drug); Placebo (Drug); TAK-438 (Drug); Placebo (Drug); Lansoprazole (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Senior Manager, Study Director, Affiliation: Takeda

Summary

The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.

Clinical Details

Official title: A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Recurrence rate of gastric or duodenal ulcer within 24 weeks

Secondary outcome:

Recurrence rate of gastric or duodenal ulcer within 12 weeks

Gastric mucosal injury

Duodenal mucosal injury

Occurrence rate of hemorrhagic lesion in stomach or duodenum

Time to recurrence of gastric or duodenal ulcer

Eligibility

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

Criteria:

Inclusion Criteria: 1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug 2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed 3. Outpatient (including inpatient for examinations) Exclusion Criteria: 1. Participants scheduled to change the type and dosage regimen of low-dose aspirin 2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed 3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 4. Participants who have a history of surgery which affects gastric acid secretion (e. g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery 5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders 6. Participants with a previous or current history of aspirin-induced asthma

Locations and Contacts

Komaki-shi, Aichi, Japan

Seto-shi, Aichi, Japan

Akita-shi, Akita, Japan

Ichikawa-shi, Chiba, Japan

Kisarazu-shi, Chiba, Japan

Matsudo-shi, Chiba, Japan

Imabari-shi, Ehime, Japan

Matsuyama-shi, Ehime, Japan

Niihama-shi, Ehime, Japan

Fukui-shi, Fukui, Japan

Chikushino-shi, Fukuoka, Japan

Fukuoka-shi, Fukuoka, Japan

Kasuya-gun, Fukuoka, Japan

Kitakyushu-shi, Fukuoka, Japan

Miyako-gun, Fukuoka, Japan

Onga-gun, Fukuoka, Japan

Yanagawa-shi, Fukuoka, Japan

Yukuhashi-shi, Fukuoka, Japan

Koriyama-shi, Fukushima, Japan

Gifu-shi, Gifu, Japan

Takasaki-shi, Gunma, Japan

Fukuyama-shi, Hiroshima, Japan

Hatsukaichi-shi, Hiroshima, Japan

Hiroshima-shi, Hiroshima, Japan

Asahikawa-shi, Hokkaido, Japan

Obihiro-shi, Hokkaido, Japan

Sapporo-shi, Hokkaido, Japan

Tomakomaki-shi, Hokkaido, Japan

Kobe-shi, Hyougo, Japan

Nishinomiya-shi, Hyougo, Japan

Takarazuka-shi, Hyougo, Japan

Koga-shi, Ibaragi, Japan

Tsuchiura-shi, Ibaragi, Japan

Kanazawa-shi, Ishikawa, Japan

Komatsu-shi, Ishikawa, Japan

Nomi-shi, Ishikawa, Japan

Shiroyama-shi, Ishikawa, Japan

Takamatsu-shi, Kagawa, Japan

Ibusuki-shi, Kagoshima, Japan

Ichikikushikino-shi, Kagoshima, Japan

Izumi-shi, Kagoshima, Japan

Atsugi-shi, Kanagawa, Japan

Kawasaki-shi, Kanagawa, Japan

Sagamihara-shi, Kanagawa, Japan

Yokohama-shi, Kanagawa, Japan

Kochi-shi, Kochi, Japan

Kumamoto-shi, Kumamoto, Japan

Kyoto-shi, Kyoto, Japan

Uji-shi, Kyoto, Japan

Tsu-shi, Mie, Japan

Sendai-shi, Miyagi, Japan

Nagasaki-shi, Nagasaki, Japan

Nara-shi, Nara, Japan

Niigata-shi, Niigata, Japan

Oita-shi, Oita, Japan

Osaka-shi, Osaka, Japan

Sakai-shi, Osaka, Japan

Tondabayashi-shi, Osaka, Japan

Ageo-shi, Saitama, Japan

Hiki-gun, Saitama, Japan

Kumagaya-shi, Saitama, Japan

Saitama-shi, Saitama, Japan

Sayama-shi, Saitama, Japan

Tokorozawa-shi, Saitama, Japan

Otsu-shi, Shiga, Japan

Utsunomiya-shi, Tochigi, Japan

Adachi-ku, Tokyo, Japan

Hachioji-shi, Tokyo, Japan

Koto-ku, Tokyo, Japan

Meguro-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Tonami-shi, Toyama, Japan

Toyama-shi, Toyama, Japan

Iwakuni-shi, Yamaguchi, Japan

Shimonoseki-shi, Yamaguchi, Japan

Additional Information

Starting date: October 2011
Last updated: January 17, 2014

Page last updated: August 23, 2015

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