Gastrointestinal LesionsPhase 1NCT02632812
Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo
A Phase 1 study testing Rebamipide effervescent granules and Naproxen tablet in people with Gastrointestinal Lesions, run by Biolab Sanus Farmaceutica.
Trial summary
This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24 participants (12 per treatment group), male or female, aged 18 years-old and above. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Lesions
- What is being tested?
- Rebamipide effervescent granules and Naproxen tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Nov 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female study participants, aged 18 years-old and above; women cannot be pregnant or breastfeeding;
- Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2;
- Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Who cannot join
- Known hypersensitivity to the investigational products (naproxen or rebamipide) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
- Subject does not present intact superior gastrointestinal mucosa, i.e., presenting bleeding, ulcers and apparent injuries in baseline endoscopy;
- Subject has achlorhydria (intragastric pH > 6.5);
- History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism;
- Chronic therapy with any drugs, except oral contraceptives;
- History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure;
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- Occult blood in the stool before treatment;
- Electrocardiographic findings that, at investigator criteria, are not recommended for study participation;
- Deviations on screening laboratory results that are considered as clinically relevant by the principal investigator;
- History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day);
- Use of regular medications within 2 weeks prior study enrollment or use of any medications within one week prior to study enrollment, except oral contraceptives or cases which, based on drug's or metabolite's half-life, complete elimination can be assumed;
- Treatment, within 6 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
- Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
- Any condition, according to investigator's best judgement, that prevents the subject to participate in the trial;
- Pregnancy, labor or miscarriage with 12 weeks before admission predicted date.
About this study
Official title: Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days
This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24 participants (12 per treatment group), male or female, aged 18 years-old and above.
Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for seven days, in reduction of gastric events caused by naproxen. Secondary objective is to evaluate safety and tolerability of rebamipide after multiple administrations.
Read more
Participants will receive either rebamipide + naproxen or placebo + naproxen, as above, during 7 consecutive days, which will be accompanied by a follow-up visit.
Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool will be performed, before and after treatment.
From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis will be performed.
- Conditions
- Gastrointestinal Lesions
- Being tested
- Rebamipide effervescent granules, Placebo effervescent granules, Naproxen tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide effervescent granulesDrug
Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
Placebo effervescent granulesDrug
Placebo effervescent granules (oral), twice daily for 7 days
Naproxen tabletDrug
Naproxen tablet 550mg (tablet), twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide & Naproxen | Experimental | Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days Receives: Drug: Rebamipide effervescent granules; Drug: Naproxen tablet |
| Placebo & Naproxen | Placebo comparator | Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days Receives: Drug: Placebo effervescent granules; Drug: Naproxen tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Score - Cryer Score
Cryer score according to gastroduodenal mucosal injury:
0 = Normal or erythema
- = Any amount of submucosal hemorrhage or edema without erosions
- = 1 erosion +- submucosal hemorrhage or edema
- = 2-4 erosions +- submucosal hemorrhage or edema
- = 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema
- = Multiple ulcers +- submucosal hemorrhage or edema - Ulcer
Measured: 8 days
Endoscopic Score - Modified Lanza Score
Modified Lanza score according to gastroduodenal mucosal injury:
0 = No hemorrhage or erosion observed
- = One or two hemorrhages or erosions observed in one gastric area
- = Three to five hemorrhages or erosions observed in one gastric area
- = Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach
- = Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach
- = Ulcer
Measured: 8 days
Histopathological Score
Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation
- = Chronic gastritis without activity
- = Chronic gastritis with activity on antrum
- = Chronic gastritis with activity on the body
- = Chronic gastritis with activity on antrum and on the body
Measured: 8 days
Intragastric pH
Measured: 8 days
Presence of H. Pylori by Biopsy
Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)
Measured: 8 days
Prostaglandin Level (PGE2 Quantification)
Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)
Measured: 8 days
Secondary outcomes (1)
Number of Adverse Events
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal LesionsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632812
- Sponsor's protocol ID
- GDN 025/14
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2015
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gagliano-Juca T, Moreno RA, Zaminelli T, Napolitano M, Magalhaes AF, Carvalhaes A, Trevisan MS, Wallace JL, De Nucci G. Rebamipide does not protect against naproxen-induced gastric damage: a randomized double-blind controlled trial. BMC Gastroenterol. 2016 Jun 4;16(1):58. doi: 10.1186/s12876-016-0472-x.
PubMed 27259970
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days
- ClinicalTrials.gov ID
- NCT02632812
- Acronym / sponsor ID
- GDN 025/14
- Conditions
- Gastrointestinal Lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a double-blind, placebo-controlled, randomized, parallel trial to evaluate if rebamipide reduces the number of gastric events caused by naproxen. Sample size is 24 participants (12 per treatment group), male or female, aged 18 years-old and above.
Primary objective is to compare rebamipide effervescent granules 100 mg twice daily, plus naproxen (coated tablets) 550 mg twice daily to placebo plus naproxen 550 mg twice daily, for seven days, in reduction of gastric events caused by naproxen. Secondary objective is to evaluate safety and tolerability of rebamipide after multiple administrations.
Participants will receive either rebamipide + naproxen or placebo + naproxen, as above, during 7 consecutive days, which will be accompanied by a follow-up visit.
Gastric integrity will be assessed, before and after treatment, by endoscopy, with stomach biopsies and detection of H. pylori. Additionally, detection of occult blood in the stool will be performed, before and after treatment.
From the above-mentioned biopsies, dosage of prostaglandin E2 and histopathological analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rebamipide & Naproxen | Experimental | Drug: Rebamipide effervescent granules, Drug: Naproxen tabletRebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days |
| Placebo & Naproxen | Placebo comparator | Drug: Placebo effervescent granules, Drug: Naproxen tabletSugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female study participants, aged 18 years-old and above; women cannot be pregnant or breastfeeding;
- Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2;
- Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Key exclusion criteria (15 listed)
- Known hypersensitivity to the investigational products (naproxen or rebamipide) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug;
- Subject does not present intact superior gastrointestinal mucosa, i.e., presenting bleeding, ulcers and apparent injuries in baseline endoscopy;
- Subject has achlorhydria (intragastric pH > 6.5);
- History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism;
- Chronic therapy with any drugs, except oral contraceptives;
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 |
|---|---|---|
| Rebamipide effervescent granulesRebamipide effervescent granules 100mg (oral), twice daily for 7 days | Drug | Rebamipide & Naproxen |
| Placebo effervescent granulesPlacebo effervescent granules (oral), twice daily for 7 days | Drug | Placebo & Naproxen |
| Naproxen tabletNaproxen tablet 550mg (tablet), twice daily for 7 days | Drug | Placebo & Naproxen, Rebamipide & Naproxen |
Primary outcome
Endoscopic Score - Cryer Score
Time frame: 8 days
Cryer score according to gastroduodenal mucosal injury: 0 = Normal or erythema 1. = Any amount of submucosal hemorrhage or edema without erosions 2. = 1 erosion +- submucosal hemorrhage or edema 3. = 2-4 erosions +- submucosal hemorrhage or edema 4. = 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema 5. = Multiple ulcers +- submucosal hemorrhage or edema - Ulcer
Endoscopic Score - Modified Lanza Score
Time frame: 8 days
Modified Lanza score according to gastroduodenal mucosal injury: 0 = No hemorrhage or erosion observed 1. = One or two hemorrhages or erosions observed in one gastric area 2. = Three to five hemorrhages or erosions observed in one gastric area 3. = Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach 4. = Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach 5. = Ulcer
Histopathological Score
Time frame: 8 days
Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation 1. = Chronic gastritis without activity 2. = Chronic gastritis with activity on antrum 3. = Chronic gastritis with activity on the body 4. = Chronic gastritis with activity on antrum and on the body
Intragastric pH
Time frame: 8 days
Presence of H. Pylori by Biopsy
Time frame: 8 days
Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)
Prostaglandin Level (PGE2 Quantification)
Time frame: 8 days
Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)
1 secondary outcome
Number of Adverse Events
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27259970Gagliano-Juca T, Moreno RA, Zaminelli T, Napolitano M, Magalhaes AF, Carvalhaes A, Trevisan MS, Wallace JL, De Nucci G. Rebamipide does not protect against naproxen-induced gastric damage: a randomized double-blind controlled trial. BMC Gastroenterol. 2016 Jun 4;16(1):58. doi: 10.1186/s12876-016-0472-x.
- 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, PhD principal investigator
Galeno Desenvolvimento de Pesquisas Ltda.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rebamipide effervescent granules and Naproxen tablet in people with Gastrointestinal Lesions, run by Biolab Sanus Farmaceutica.
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 4 inclusion and 15 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endoscopic Score - Cryer Score (time frame: 8 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632812, which also lists 1 linked publication.
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 20 Mar 2017.