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Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo

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ClinicalTrials.gov Identifier: NCT02632812
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Gastrointestinal Lesions Drug: Rebamipide effervescent granules Drug: Placebo effervescent granules Drug: Naproxen tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rebamipide & Naproxen
Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days
Drug: Rebamipide effervescent granules
Rebamipide effervescent granules 100mg (oral), twice daily for 7 days

Drug: Naproxen tablet
Naproxen tablet 550mg (tablet), twice daily for 7 days

Placebo Comparator: Placebo & Naproxen
Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days
Drug: Placebo effervescent granules
Placebo effervescent granules (oral), twice daily for 7 days

Drug: Naproxen tablet
Naproxen tablet 550mg (tablet), twice daily for 7 days




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Intragastric pH [ Time Frame: 8 days ]
  5. Presence of H. Pylori by Biopsy [ Time Frame: 8 days ]
    Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)

  6. 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)


Secondary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632812


Sponsors and Collaborators
Biolab Sanus Farmaceutica
Investigators
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Principal Investigator: Gilberto De Nucci, PhD Galeno Desenvolvimento de Pesquisas Ltda.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier: NCT02632812    
Other Study ID Numbers: GDN 025/14
First Posted: December 17, 2015    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Naproxen
Rebamipide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Protective Agents