Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01452750
First received: September 16, 2011
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 non-steroidal anti-Inflammatory drug (NSAID).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Non-steroidal Anti-inflammatory Drug (NSAID).

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Gastric mucosal injury [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Duodenal mucosal injury [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 642
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants who require continuous NSAID 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 NSAID
  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 ClinicalTrials.gov identifier: NCT01452750

  Hide Study Locations
Locations
Japan
Kasugai-shi, Aichi, Japan
Nagoya-shi, Aichi, Japan
Seto-shi, Aichi, Japan
Akita-shi, Akita, Japan
Funabashi-shi, Chiba, Japan
Ichihara-shi, Chiba, Japan
Nagareyama-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Niihama-shi, Ehime, Japan
Saijo-shi, Ehime, Japan
Fukui-shi, Fukui, Japan
Fukuoka-shi, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kitakyusyu-shi, Fukuoka, Japan
Munakata-shi, Fukuoka, Japan
Onga-gun, Fukuoka, Japan
Tagawa-shi, Fukuoka, Japan
Yukuhashi-shi, Fukuoka, Japan
Fukushima-shi, Fukushima, Japan
Koriyama-shi, Fukushima, Japan
Gifu-shi, Gifu, Japan
Mebashi-shi, Gunma, Japan
Takasaki-shi, Gunma, Japan
Fukuyama-shi, Hiroshima, Japan
Hatsukaichi-shi, Hiroshima, Japan
Higashihirosima-shi, Hiroshima, Japan
Asahikawa-shi, Hokkaido, Japan
Hakodate-shi, Hokkaido, Japan
Obihiro-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Sunagawa-shi, Hokkaido, Japan
Tomakomai-shi, Hokkaido, Japan
Akashi-shi, Hyogo, Japan
Himeji-shi, Hyogo, Japan
Itami-shi, Hyogo, Japan
Kako-gun, Hyogo, Japan
Kato-shi, Hyogo, Japan
Kobe-shi, Hyogo, Japan
Nishinomiya-shi, Hyogo, Japan
Higashiibaragi-gun, Ibaragi, Japan
Koga-shi, Ibaragi, Japan
Mito-shi, Ibaragi, Japan
Hitachi-shi, Ibaraki, Japan
Hakusan-shi, Ishikawa, Japan
Komatsu-shi, Ishikawa, Japan
Takamatsu-shi, Kagawa, Japan
Kamakura-shi, Kanagawa, Japan
Kawasaki-shi, Kanagawa, Japan
Sagamihara-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Kochi-shi, Kochi, Japan
Kumamoto-shi, Kumamoto, Japan
Uji-shi, Kyoto, Japan
Tsu-shi, Mie, Japan
Sendai-shi, Miyagi, Japan
Matsumoto-shi, Nagano, Japan
Nagano-shi, Nagano, Japan
Nagasaki-shi, Nagasaki, Japan
Ikoma-shi, Nara, Japan
Nara-shi, Nara, Japan
Nigata-shi, Nigata, Japan
Beppu-shi, Oita, Japan
Oita-shi, Oita, Japan
Yuhu-shi, Oita, Japan
Kurashiki-shi, Okayama, Japan
Higashiosaka-shi, Osaka, Japan
Moriguchi-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Osakasayama-shi, Osaka, Japan
Tondabayashi-shi, Osaka, Japan
Ogi-shi, Saga, Japan
Saga-shi, Saga, Japan
Ageo-shi, Saitama, Japan
Hiki-gun, Saitama, Japan
Kasukabe-shi, Saitama, Japan
Kumagaya-shi, Saitama, Japan
Saitama-shi, Saitama, Japan
Sayama-shi, Saitama, Japan
Toda-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Otsu-shi, Shiga, Japan
Izumo-shi, Shimane, Japan
Hamamatsu-shi, Shizuoka, Japan
Shizuoka-shi, Shizuoka, Japan
Naruto-shi, Tokushima, Japan
Adachi-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Hachiouji-shi, Tokyo, Japan
Koto-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Musashimurayama-shi, Tokyo, Japan
Nakano-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Sumida-ku, Tokyo, Japan
Yonago-shi, Tottori, Japan
Tonami-shi, Toyama, Japan
Toyama-shi, Toyama, Japan
Shimonoseki-shi, Yamaguchi, Japan
Ube-shi, Yamaguchi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01452750     History of Changes
Other Study ID Numbers: TAK-438/CCT-301, U1111-1123-8722, JapicCTI-111613
Study First Received: September 16, 2011
Last Updated: February 4, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Duodenal Diseases
Intestinal Diseases
Anti-Inflammatory Agents
Lansoprazole
Dexlansoprazole
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014