NCT04885751

Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy

Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Seoul National University Boramae Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy of eupatilin on the prevention of gastroenteropathy in patients with NSAIDs and low dose steroid by comparing with rebamipide.

Detailed 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 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.

Conditions

• Rheumatoid Arthritis
• Osteoarthritis
• Ankylosing Spondylitis
• Other Musculoskeletal Disorder
• Gastric Ulcer
• Enteritis
• NSAID-Associated Gastropathy
• NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy

Interventions

Type	Name	Description
DRUG	Eupatilin	take eupatilin to prevent NSAID induced gastroenteropathy
DRUG	Rebamipide	take rebamipide to prevent NSAID induced gastroenteropathy

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-05-13
• Last updated: 2021-05-13