Gastric LesionPhase 3NCT03658473
Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions
A Phase 3 study testing 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole. in people with Gastric Lesion, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Lesion
- What is being tested?
- 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Nov 2014to 4 Feb 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Galeno Desenvolvimento de Pesquisas Clinicas Ltda.
Campinas, São Paulo, 13087-010
About this study
Official title: 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.
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.
Read the 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
- Being tested
- 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole., 550 mg naproxen + placebo + 20 mg rabeprazole, 550 mg naproxen + 300 mg rebamipide + placebo, 550 mg naproxen + placebo + placebo
- Keywords
- gastroprotection, rebamipide, rabeprazole, naproxeno
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
550 mg naproxen + 300 mg rebamipide + placeboDrug
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 + placeboDrug
Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: 550 mg naproxen + placebo + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-7 days after drugs administration
Secondary outcomes (2)
Measurement of prostaglandin levels (PGE2).
Measurement of prostaglandin levels (PGE2) in biopsy specimens collected before and after treatment of each subject.
Measured: 0-7 days after drugs administration
Number of adverse events per participant
Number of adverse events in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results.
Measured: 0-7 days after drugs administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start12 Nov 2014
- Primary completion27 Nov 2014
- Study completion4 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
- Sponsor type
- Other government
- Collaborators
- Biolab Sanus Farmaceutica
- Responsible party
- Principal investigator, Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
- Investigators
- Gilberto De Nucci, Doctor, Principal investigator, Galeno Desenvolvimento de Pesquisas Clinicas Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658473
- Sponsor's protocol ID
- GDN 005/15
- Status last verified
- Sep 2018
- First submitted
- 1 Sep 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03658473
- Acronym / sponsor ID
- GDN 005/15
- Conditions
- Gastric Lesion
- Keywords
- gastroprotection, rebamipide, rabeprazole, naproxeno
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas ClínicasOther government
- Collaborators
- Biolab Sanus Farmaceutica
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 27 Nov 2014 (actual)
- Study completion
- 4 Feb 2015 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.Administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days. |
| Treatment B | Active comparator | Drug: 550 mg naproxen + placebo + 20 mg rabeprazoleAdministration of 550 mg naproxen 2x daily + 300 mg rebamipide placebo 2x daily + 20 mg rabeprazole 1x daily over 7 days. |
| Treatment C | Active comparator | Drug: 550 mg naproxen + 300 mg rebamipide + placeboAdministration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole placebo 1x daily over 7 days. |
| Treatment D | Placebo comparator | Drug: 550 mg naproxen + placebo + placeboAdministration of 550 mg naproxen 2x daily + 300 mg rebamipide placebo 2x daily + 20 mg rabeprazole placebo 1x daily over 7 days. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treatment A |
| 550 mg naproxen + placebo + 20 mg rabeprazoleOral administration of 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days. | Drug | Treatment B |
| 550 mg naproxen + 300 mg rebamipide + placeboOral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days. | Drug | Treatment C |
| 550 mg naproxen + placebo + placeboOral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days. | Drug | Treatment D |
Primary outcome
Evaluation of the number of gastric events (erosion of the gastric mucosa, gastritis, petechiae in the gastric mucosa and ulcer)
Time frame: 0-7 days after drugs administration
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.
2 secondary outcomes
Measurement of prostaglandin levels (PGE2).
Time frame: 0-7 days after drugs administration
Number of adverse events per participant
Time frame: 0-7 days after drugs administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto De Nucci, Doctor principal investigator
Galeno Desenvolvimento de Pesquisas Clinicas Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole. in people with Gastric Lesion, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the number of gastric events (erosion of the gastric mucosa, gastritis, petechiae in the gastric mucosa and ulcer) (time frame: 0-7 days after drugs administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.