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Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

NCT02632812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-03-20

Study results available
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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

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

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • Gilberto De Nucci, PhD · Galeno Desenvolvimento de Pesquisas Ltda.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632812 on ClinicalTrials.gov