NCT02632812

Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24 participants (12 per treatment group), male or female, aged 18 years-old and above. Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for seven days, in reduction of gastric events caused by naproxen. Secondary objective is to evaluate safety and tolerability of rebamipide after multiple administrations. Participants will receive either rebamipide + naproxen or placebo + naproxen, as above, during 7 consecutive days, which will be accompanied by a follow-up visit. Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool will be performed, before and after treatment. From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis will be performed.

Conditions

• Gastrointestinal Lesions

Interventions

Type	Name	Description
DRUG	Rebamipide effervescent granules	Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
DRUG	Placebo effervescent granules	Placebo effervescent granules (oral), twice daily for 7 days
DRUG	Naproxen tablet	Naproxen tablet 550mg (tablet), twice daily for 7 days

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2015-12-17
• Last updated: 2017-03-20
• Results posted: 2017-03-20