Gastrointestinal Integrity After Naproxen + Rebamipide Versus

Gastrointestinal Integrity After Naproxen + Rebamipide Versus
Naproxen + Placebo
Status: Completed
Study Phase: Phase 1
Start Date: October 2014 | Completion Date: December 2014
Condition(s): Gastrointestinal Lesions
Full Title of Study
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
Overview
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.
Study Details
Study Type
: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study,
Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Primary Purpose: Treatment
Investigator Details
Lead Sponsor: Biolab Sanus Farmaceutica
Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.
Interventions
Drug: Rebamipide effervescent granules
Drug: Placebo effervescent granules
Drug: Naproxen tablet
Information Source
ID Number: GDN 025/14
NCT Identifier: NCT02632812
Health Authority: Brazil: Comitê de Ética em Pesquisa do Instituto de Ciências Biomédicas da Universidade de
São Paulo
Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT02632812
ClinicalTrials.gov processed this data on September 29, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
by this site. Please see the full source link above for retrieving further details from the government database.