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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00576706 |
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Date of registration:
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17/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
PRESENT |
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Scientific title:
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A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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396 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00576706 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Soo-Heon Park, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Catholic University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Signed written informed consent after being informed of the clinical trial
2. Males or females 19 years of age
3. Intake of any brand of NSAIDs in more than half of daily dose for at least the
previous 4 weeks.
Exclusion Criteria:
1. Necessary to proceed in concomitant treatment with epileptic medications,
anti-chollinergics, prokinetics, sucralfate
2. Presence or history of allergic drug reaction to the following medications;
rebamipide, Misoprostol, NSAIDs designated to the protocol
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Ankylosing Spondylitis
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Misoprostol
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Drug: Rebamipide
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Primary Outcome(s)
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Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Rate of Therapeutic failure
[Time Frame: 12 weeks]
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Severity of gastrointestinal symptoms
[Time Frame: 12 weeks]
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Antacid consumption
[Time Frame: 12 weeks]
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Secondary ID(s)
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037-KOA-0701i
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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