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Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions

NCT03658473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-09-05

No results posted yet for this study

Summary

This clinical trial evaluated the gastroprotection obtained by the use of rebamipide 300 mg (2x daily) and rabeprazole 20 mg/day (1x daily) associated or not in the prevention of gastric lesions induced by naproxen 1100 mg/day) for 7 days to healthy volunteers of both sexes. This trial also assessed drugs safety and tolerability, the prostaglandin levels (PGE2) in biopsy specimens before and after treatment of each group and the histopathological changes induced by the treatment of each group.

Conditions

  • Gastric Lesion

Interventions

DRUG

550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.

Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + placebo + 20 mg rabeprazole

Oral administration of 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + 300 mg rebamipide + placebo

Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days.

DRUG

550 mg naproxen + placebo + placebo

Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    collaborator INDUSTRY

  • Galeno Desenvolvimento de Pesquisas Clínicas

    lead OTHER_GOV

Principal Investigators

  • Gilberto De Nucci, Doctor · Galeno Desenvolvimento de Pesquisas Clinicas Ltda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-12
Primary Completion
2014-11-27
Completion
2015-02-04

Countries

  • Brazil

Study Locations

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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 NCT03658473 on ClinicalTrials.gov