- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01568385
A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy
February 7, 2014 updated by: Takeda
The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy will be investigated.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba
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Funabashi-shi, Chiba, Japan
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Noda-shi, Chiba, Japan
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan
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Gunma
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Annaka-shi, Gunma, Japan
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan
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Hokkaido
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Hakodate-shi, Hokkaido, Japan
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Kitahiroshima-shi, Hokkaido, Japan
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Sapporo-shi, Hokkaido, Japan
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Yubari-gun, Hokkaido, Japan
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Ishikawa
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Kanazawa-shi, Ishikawa, Japan
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Kagawa
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Sanuki-shi, Kagawa, Japan
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Kumamoto
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Yashiro-shi, Kumamoto, Japan
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Nagasaki
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Nagasaki-shi, Nagasaki, Japan
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Sasebo-shi, Nagasaki, Japan
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Tokyo
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Fuchu-shi, Tokyo, Japan
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Katsushika-ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Nakano-ku, Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
- Prior to study commencement, participants who are capable of signing and dating the information/consent form.
- Participants with a chronic disease (rheumatoid arthritis, osteoarthritis, etc.) which requires continuous NSAID oral therapy for pain control during treatment period.
Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
- Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
- Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
- Outpatient participants (inpatients for examinations are acceptable)
- Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose
Exclusion Criteria:
- Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
- Participants who have previously received TAK-438 in a clinical study or as a treatment
- Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
- Participants who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
- Participants with a plan to change the type, dosage or administration of NSAID
- Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
- Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
- Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
- Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with a history or complication of aspirin asthma
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or NSAIDs
- Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
- Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
- Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
- Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia
- Participants who plan to undergo surgery requiring hospitalization or requires surgery during the study period.
- Participants with a history of a malignancy (or treatment thereof) within 5 years prior to the commencement of screening; however, participants with completely cured basal cell carcinoma of skin or carcinoma in situ of the cervix may be included in the study.
- Participants with acquired immune deficiency syndrome (AIDS; including HIV carriers) or hepatitis (including viral hepatitis carriers [HBs antigen or HCV antibody positive]); however, participants who are hepatitis C virus (HCV) antigen negative or HCV-RNA negative may be included in the study.
Participants who meet either of the following laboratory test values at the beginning of screening (Visit 1)
- Serum creatinine value: higher than 2 mg/dL
- Alanine transaminase (ALT) or aspartate aminotransferase (AST): higher than 2.5 × the upper limit of normal
- Total bilirubin: higher than 2.0 × the upper limit of normal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TAK-438 20 mg QD
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse Event
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
March 29, 2012
First Submitted That Met QC Criteria
March 30, 2012
First Posted (Estimate)
April 2, 2012
Study Record Updates
Last Update Posted (Estimate)
February 10, 2014
Last Update Submitted That Met QC Criteria
February 7, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAK-438/OCT-303
- U1111-1128-5905 (Registry Identifier: WHO)
- JapicCTI-121789 (Registry Identifier: JapicCTI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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