Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ankylosing Spondylitis
- Enteritis
- Gastric Ulcer
- NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy
- NSAID-Associated Gastropathy
- Osteoarthritis
- Other Musculoskeletal Disorder
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 19 years and 70 years
- Gender
- Both males and females
Description
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At w...
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At week 0, subjects who meet the eligibility criteria will be randomized in a open labeled manner in 1:1 ratio to eupatilin (90mg twice daily-test group, 25 patients) or rebamipide (100mg three times daily-control group paients) for 8 weeks. At week 8, subjects undergo fecal calprotectin test, upper endoscopy and submit symptom diary.
Tracking Information
- NCT #
- NCT04885751
- Collaborators
- Dong-A ST Co., Ltd.
- Investigators
- Not Provided
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