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

NCT03658473 | Completed Phase 3

• 1 other identifier: GDN 005/15
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gastroprotection; rebamipide; rabeprazole; naproxeno

Outcome Measures

Primary Outcomes (1)

• Evaluation of the number of gastric events (erosion of the gastric mucosa, gastritis, petechiae in the gastric mucosa and ulcer)

  Histopathological examination of biological samples (biopsies) in the antrum region and in the gastric body collected during the upper digestive endoscopy performed before the beginning of the therapies and 12 hours after the last administration (8th day of the study) to each subject.

  0-7 days after drugs administration

Secondary Outcomes (2)

• Measurement of prostaglandin levels (PGE2).

  0-7 days after drugs administration

• Number of adverse events per participant

  0-7 days after drugs administration

Study Arms (4)

Treatment A

ACTIVE COMPARATOR

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

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

Treatment B

ACTIVE COMPARATOR

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

Drug: 550 mg naproxen + placebo + 20 mg rabeprazole

Treatment C

ACTIVE COMPARATOR

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

Drug: 550 mg naproxen + 300 mg rebamipide + placebo

Treatment D

PLACEBO COMPARATOR

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

Drug: 550 mg naproxen + placebo + placebo

Interventions

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

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

Treatment A

550 mg naproxen + placebo + 20 mg rabeprazole DRUG

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

Treatment B

550 mg naproxen + 300 mg rebamipide + placebo DRUG

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

Treatment C

550 mg naproxen + placebo + placebo DRUG

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

Treatment D

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers of both sexes aged 18 or over. Women could not be pregnant or breastfeeding
• Body-mass index (BMI) ≥19.0 kg/m² and ≤ 28.75 kg/m²
• Good state of health
• Non-smoker or ex-smoker for at least 6 month
• Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

You may not qualify if:

• Existing cardiac, hepatic and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability and/or pharmacokinetics and/or pharmacodynamics of the active ingredient
• History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
• Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations
• Subjects with severe allergies or multiple drug allergies, unless it is judged as not relevant for the clinical trial by the investigator
• Volunteer does not present the entire upper gastrointestinal tract mucosa, that is, hemorrhages, ulcers or apparent lesions at the first endoscopic examination.
• The volunteer that has achlorhydria (intragastric pH greater than 6.5)
• Occult blood in the faeces with positive result before the start of therapy
• Electrocardiographic findings not recommended by the researcher for participation in the study
• Deviations from the results of laboratory recruitment examinations considered clinically relevant by the researcher
• Has a history of alcohol or drug abuse or expressive alcohol consumption (\> 35g/day)
• Participation in a clinical trial during the last 6 months prior to individual enrolment of the subject
• Have used regular medication within 2 weeks prior to initiation of treatment or used any medication within one week prior to initiation of study treatment, with the exception of oral contraceptives or cases where, based on half-life of the drug and/or active metabolites, complete elimination may be assumed
• Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda.

Campinas, São Paulo, 13087-010, Brazil

Location

MeSH Terms

Interventions

Naproxen; rebamipide; Rabeprazole

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gilberto De Nucci, Doctor

  Galeno Desenvolvimento de Pesquisas Clinicas Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: September 5, 2018
• Study Start: November 12, 2014
• Primary Completion: November 27, 2014
• Study Completion: February 4, 2015
• Last Updated: September 5, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)