Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions
NCT ID: NCT03658473
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
32 participants
INTERVENTIONAL
2014-11-12
2015-02-04
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Treatment A
Administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.
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.
Treatment B
Administration of 550 mg naproxen 2x daily + 300 mg rebamipide placebo 2x daily + 20 mg rabeprazole 1x daily over 7 days.
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.
Treatment C
Administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole placebo 1x daily over 7 days.
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.
Treatment D
Administration of 550 mg naproxen 2x daily + 300 mg rebamipide placebo 2x daily + 20 mg rabeprazole placebo 1x daily over 7 days.
550 mg naproxen + placebo + placebo
Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.
Interventions
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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.
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.
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.
550 mg naproxen + placebo + placebo
Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
55 Years
ALL
Yes
Sponsors
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Biolab Sanus Farmaceutica
INDUSTRY
Galeno Desenvolvimento de Pesquisas Clínicas
OTHER_GOV
Responsible Party
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Gilberto De Nucci
Doctor
Principal Investigators
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Gilberto De Nucci, Doctor
Role: PRINCIPAL_INVESTIGATOR
Galeno Desenvolvimento de Pesquisas Clinicas Ltda
Locations
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Galeno Desenvolvimento de Pesquisas Clinicas Ltda.
Campinas, São Paulo, Brazil
Countries
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Other Identifiers
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GDN 005/15
Identifier Type: -
Identifier Source: org_study_id
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