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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

This study has been completed.
Information provided by (Responsible Party):
Takeda Identifier:
First received: September 16, 2011
Last updated: January 17, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Gastric Ulcers
Duodenal Ulcers
Drug: TAK-438
Drug: Placebo
Drug: Lansoprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ]
    Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.

Secondary Outcome Measures:
  • Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ]
  • Gastric mucosal injury [ Time Frame: 24 Weeks ]
  • Duodenal mucosal injury [ Time Frame: 24 weeks ]
  • Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ]
  • Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ]

Enrollment: 621
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD Drug: TAK-438
TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Active Comparator: Lansoprazole 15 mg QD Drug: Lansoprazole
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
Other Name: AG-1749
Drug: Placebo
TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01452763

  Hide Study Locations
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
Sponsors and Collaborators
Study Director: Senior Manager Takeda
  More Information

Responsible Party: Takeda Identifier: NCT01452763     History of Changes
Other Study ID Numbers: TAK-438/CCT-302
U1111-1123-8746 ( Registry Identifier: WHO (UTN) )
JapicCTI-111610 ( Registry Identifier: JapicCTI )
Study First Received: September 16, 2011
Last Updated: January 17, 2014

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents processed this record on April 28, 2017