Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Lesion

Keywords

gastroprotectionrebamipiderabeprazolenaproxeno

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.

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 rabeprazoleDrug

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

Treatment B

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age20 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Biolab Sanus Farmaceutica
Industrycollaborator
Galeno Desenvolvimento de Pesquisas Clínicas
Governmentlead

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda.

Campinas, São Paulo, 13087-010, Brazil

MeSH Terms

Interventions

NaproxenrebamipideRabeprazole

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridines

Study Officials

Gilberto De Nucci, Doctor
Galeno Desenvolvimento de Pesquisas Clinicas Ltda
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Treatment A

Treatment B

Treatment C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Treatment D

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

Treatment A

Treatment B

Treatment C

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Treatment D

You may not qualify if:

Data Sharing

Source record

Locations