Gastrointestinal Lesions Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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