Study Stopped
AG-1749 superior to Gefarnate in ulcer prevention
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
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.
4 other identifiers
interventional
461
1 country
65
Brief Summary
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2007
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
May 10, 2011
CompletedFebruary 3, 2012
February 1, 2012
1.5 years
September 26, 2008
February 3, 2011
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
18 Months
Secondary Outcomes (47)
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
Baseline and Month 3.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
Baseline and Month 6.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
Baseline and Month 9.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Baseline and Month 18.
- +42 more secondary outcomes
Study Arms (2)
Lansoprazole 15 mg QD
EXPERIMENTALGefarnate 50 mg BID
ACTIVE COMPARATORInterventions
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Eligibility Criteria
You may qualify if:
- The patient was 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.
- The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.
You may not qualify if:
- Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
- Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
- Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
- Past or planned surgery affecting gastric acid secretion.
- Clinically significant hepatic or renal disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (65)
Unknown Facility
Matsudo-shi, Chiba, Japan
Unknown Facility
Yotsukaido-shi, Chiba, Japan
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Imabari, Ehime, Japan
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Matsuyama, Ehime, Japan
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Fukui-shi, Fukui, Japan
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Fukuoka, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Gifu, Gifu, Japan
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Fujioka-shi, Gunma, Japan
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Maebashi, Gunma, Japan
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Higashihiroshima-shi, Hiroshima, Japan
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Hiroshima, Hiroshima, Japan
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Kure-shi, Hiroshima, Japan
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Asahikawa-shi, Hokkaido, Japan
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Hakodate-shi, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Higashiibaraki-gun, Ibaraki, Japan
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Hitachi-Naka, Ibaraki, Japan
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Inashiki-gun, Ibaraki, Japan
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Namegata-shi, Ibaraki, Japan
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Tsuchiura-shi, Ibaraki, Japan
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Yuuki-shi, Ibaraki, Japan
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Hakusan-shi, Ishikawa-ken, Japan
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Kanazawa, Ishikawa-ken, Japan
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Komatsu-shi, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Fujisawa-shi, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Yamato-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka-shi, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Matsusaka-shi, Mie-ken, Japan
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Shima-shi, Mie-ken, Japan
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Tsu, Mie-ken, Japan
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Sendai, Miyagi, Japan
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Ebino-shi, Miyazaki, Japan
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Miyazaki, Miyazaki, Japan
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Jōetsu, Niigata, Japan
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Niigata, Niigata, Japan
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Beppu-shi, Ooita, Japan
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Ōita, Ooita, Japan
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Ibaraki-shi, Osaka, Japan
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Matsubara-shi, Osaka, Japan
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Osaka, Osaka, Japan
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Takatsuki-shi, Osaka, Japan
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Hanyuu-shi, Saitama, Japan
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Ōtsu, Shiga, Japan
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Hamada-shi, Shimane, Japan
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Sunto-gun, Shizuoka, Japan
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Shimotsuke-shi, Tochigi, Japan
Unknown Facility
Chiyoda-ku, Tokyo, Japan
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Chuuo-ku, Tokyo, Japan
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Hachioji-shi, Tokyo, Japan
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Kiyose-shi, Tokyo, Japan
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Minato-ku, Tokyo, Japan
Unknown Facility
Shinagawa-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Toshima-ku, Tokyo, Japan
Unknown Facility
Higashitagawa-gun, Yamagata, Japan
Unknown Facility
Iwakuni-shi, Yamaguchi, Japan
Unknown Facility
Shimonoseki-shi, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
On September 2008, the Efficacy and Safety Evaluation Committee recommended that this study be discontinued based on the interim analysis.
Results Point of Contact
- Title
- Sr. VP Clinical Science
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY DIRECTOR
General Manager
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
May 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
February 3, 2012
Results First Posted
May 10, 2011
Record last verified: 2012-02