Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
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
4 other identifiers
interventional
366
1 country
68
Brief Summary
The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).
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 Apr 2007
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 6, 2008
CompletedFirst Posted
Study publicly available on registry
November 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
May 10, 2011
CompletedFebruary 3, 2012
February 1, 2012
2.1 years
November 6, 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 24 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
24 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 12)
Baseline and Month 12.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 18)
Baseline and Month 18.
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 24)
Baseline and Month 24.
- +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 6 to 24 months.
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Eligibility Criteria
You may qualify if:
- The patient was on nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs.
- Past or planned surgery affecting gastric acid secretion.
- Clinically significant hepatic or renal disorder.
- Serious cardiac dysfunction, hypertension, or hematological disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (68)
Unknown Facility
Kasugai-shi, Aichi-ken, Japan
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Yotsukaido-shi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukui-shi, Fukui, Japan
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Chikushi-gun, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kurume-shi, Fukuoka, Japan
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Munakata-shi, Fukuoka, Japan
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Onga-gun, Fukuoka, Japan
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Gifu, Gifu, Japan
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Maebashi, Gunma, Japan
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Higashihiroshima-shi, Hiroshima, Japan
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Kure-shi, Hiroshima, Japan
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Asahikawa-shi, Hokkaido, Japan
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Chitose-shi, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Kato-shi, Hyōgo, Japan
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Nishinomiya-shi, Hyōgo, Japan
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Hitachi-Naka, Ibaraki, Japan
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Yuki-shi, Ibaraki, Japan
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Hakusan-shi, Ishikawa-ken, Japan
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Komatsu-shi, Ishikawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kamakura-shi, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yamato-shi, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Susaki-shi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Ise-shi, Mie-ken, Japan
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Shima-shi, Mie-ken, Japan
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Yokkaichi-shi, 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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Miyazaki-gun, Miyazaki, Japan
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Matsumoto-shi, Nagano, Japan
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Omura-shi, Nagasaki, Japan
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Niigata, Niigata, Japan
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Beppu-shi, Oita Prefecture, Japan
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Okayama, Okayama-ken, Japan
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Daito-shi, Osaka, Japan
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Osaka, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Ogi-shi, Saga-ken, Japan
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Saga, Saga-ken, Japan
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Hanyu-shi, Saitama, Japan
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Sunto-gun, Shizuoka, Japan
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Shimotsuke-shi, Tochigi, Japan
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Naruto-shi, Tokushima, Japan
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Tokushima, Tokushima, Japan
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Chuo-ku, Tokyo, Japan
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Hachioji-shi, Tokyo, Japan
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Kiyose-shi, Tokyo, Japan
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Machida-shi, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Nishi-Tokyo-shi, Tokyo, Japan
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Shibuya-ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Toshima-ku, Tokyo, Japan
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Tottori-shi, Tottori, Japan
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Yonago-shi, Tottori, Japan
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Shimonoseki-shi, Yamaguchi, Japan
Unknown Facility
Yanai-shi, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was prematurely discontinued due to results available from a parallel study (AG-1749-CCT-351; NCT00762359) demonstrating a preventive effect on ulcer occurrence which impacted the risk/benefit profile.
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
November 6, 2008
First Posted
November 7, 2008
Study Start
April 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
February 3, 2012
Results First Posted
May 10, 2011
Record last verified: 2012-02