NCT03658473

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

Double-blind, Phase III Study to Evaluate Gastroprotection Obtained by the Use of Rebamipide 300 mg (2x Daily) and Rabeprazole 20 mg/Day (1x Daily) Associated or Not to Prevent Naproxen (1100 mg/Day)-Induced Gastric Lesions for 7 Days.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Galeno Desenvolvimento de Pesquisas Clínicas · Other Government
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This phase III, single center, double-blind, randomised, multiple-dose trial was performed in a parallel-group design. The subjects were randomly assigned to one of the 4 possible treatments: treatment A - 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days; treatment B - 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days; treatment C - 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days; and treatment D - 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days. Upper digestive endoscopy was performed before the beginning of the therapies and 12 hours after the last administration (8th day of the study), with collection of the biological samples (biopsies) in the antrum region and 5 in the gastric body at each examination. The samples were preserved in formalin solution and sent for histopathological examination. The safety and tolerability was assessed by signs and symptoms, adverse events, laboratory tests, vital signs and electrocardiogram (ECG).

Conditions

• Gastric Lesion

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-11-12
• Primary completion: 2014-11-27
• Completion: 2015-02-04
• First posted: 2018-09-05
• Last updated: 2018-09-05

Locations

1 site across 1 country: Brazil