Conditions: Gastrointestinal Lesions
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days arm 2: Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days

Interventions: intervention 1: Rebamipide effervescent granules intervention 2: Placebo effervescent granules intervention 3: Naproxen tablet
Intervention descriptions: intervention 1: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days intervention 2: Placebo effervescent granules (oral), twice daily for 7 days intervention 3: Naproxen tablet 550mg (tablet), twice daily for 7 days

Protocol document: