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EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS

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ClinicalTrials.gov Identifier: NCT04069286
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Hospital Universitário Oswaldo Cruz
Information provided by (Responsible Party):
Infan Industria Quimica Farmaceutica Nacional

Brief Summary:

This is a prospective, randomized, double - blind study of 200 male and female volunteers with gastritis diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from October 2019 to July 2020. .

Hypothesis:

As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolius raddi), associated with amoxicillin and clarithromycin, for the treatment of patients diagnosed with gastritis and dyspeptic symptoms has similar efficacy and safety (non-inferior) and/or superior efficacy and safety to traditional therapy based on the use of omeprazole-associated antibiotic therapy.


Condition or disease Intervention/treatment Phase
Gastritis Helicobacter Pylori Infection Drug: Oral Aroeira/ Amoxicillin/ Claritromycin Drug: Omeprazole/ Amoxicillin/ Claritromycin Phase 2 Phase 3

Detailed Description:

This is a prospective, randomized, double - blind study of 200 male and female volunteers with gastritis diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from October 2019 to July 2020. .

Hypothesis:

As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolius raddi), associated with amoxicillin and clarithromycin, for the treatment of patients diagnosed with gastritis and dyspeptic symptoms has similar efficacy and safety (non-inferior) and/or superior efficacy and safety to traditional therapy based on the use of omeprazole-associated antibiotic therapy.

Phase 3, double-blind, randomized, unicenter, clinical trial for patients who are diagnosed with H pylori gastritis and have associated dyspeptic symptoms seen at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic in Recife / PE, Brazil. October 2019 to July 2020.

In order to verify the hypothesis that treatment with oral Aroeira, amoxicillin and clarithromycin has similar (not inferior) and/or superior efficacy and safety than treatment with omeprazole, amoxicillin and clarithromycin, a sample of 200 patients was defined, keeping the proportion 1: 1, which will be divided into two groups:

  1. Test group with 100 patients undergoing treatment with:

    oral Aroeira (Schinus terebinthifolius Raddi, 640mg / tablet) 1 tablet every 12 hours + amoxicillin 2 500mg tablets every 12 hours + clarithromycin 1 tablet 500mg every 12 hours for 14 days.

  2. Control group with 100 patients undergoing treatment with:

omeprazole 1 20mg tablet every 12 hours + amoxicillin 2 500mg tablet every 12 hours + clarithromycin 1 tablet 500mg every 12 hours for 14 days.

At the beginning of the study, patients will answer the sociodemographic questionnaire, which includes identification data, concomitant presence of chronic diseases and time of onset of symptoms. Patients will also respond to the symptom questionnaire. At the time of upper digestive endoscopy and pathological examination, which will be performed before and after treatment completion, patients will have their results graded endoscopically, using the Sydney criteria and according to the Sydney Histological Classification. After performing the second upper digestive endoscopy and pathological examination, professionals will be instructed to answer questionnaires to evaluate the endoscopic and histological response to treatment. At the end of treatment, patients will respond to a specific treatment response questionnaire.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN COMPARED WITH CONVENTIONAL TRIPLE THERAPY FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS: A RANDOMIZED AND DOUBLE-BLIND STUDY
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treated Group
in which dry Aroeira extract (Schinus terebinthifolius raddi, 640mg / tablet) will be administered + amoxicillin 500mg 2 tablets + clarithromycin, 500mg 1 tablet given twice daily (12/12 hours).
Drug: Oral Aroeira/ Amoxicillin/ Claritromycin
Oral Aroeira (Schinus terebinthifolius Raddi, 640mg/tablet) 1 tablet, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.

Active Comparator: Control Group
in which 1 tablet of 20mg of omeprazole will be administered + amoxicillin 2 tablets of 500mg + clarithromycin, 1 tablet of 500mg administered twice daily (12/12 hours).
Drug: Omeprazole/ Amoxicillin/ Claritromycin
Omeprazole 1 tablet of 20mg, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.




Primary Outcome Measures :
  1. Definitive Cure [ Time Frame: 60 days after the first day treatment ]
    Definitive Cure: H. pylori eradication, determined by a score = 0, in relation to the quantitative presence of H. pylori (determined by the sum of antrum, angular notch, and body scores).


Secondary Outcome Measures :
  1. Parcial Cure [ Time Frame: 60 days after the first day treatment ]
    Partial Healing: Quantitative reduction in relation to the presence of H. pylori (determined by the sum of the antrum, angular notch and body scores), but without eradication.

  2. Clinical Failure [ Time Frame: 60 days after the first day treatment ]
    Clinical Failure: no response to treatment, determined by maintenance or quantitative worsening of H. pylori presence (determined by sum of antrum, angular notch, and body scores)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: Patients who:

  • Report dyspeptic symptoms (nausea, heartburn, epigastric pain, aggravated / relieved abdominal discomfort, and early satiety); Confirmação Have gastritis and H pylori confirmed by upper digestive endoscopy and pathological examination;
  • are between 18 and 80 years old;
  • Understand and sign the Informed Consent Form.

Exclusion criteria: Patients who:

  • Are being treated with proton pump inhibitor, non-steroidal anti-inflammatory drugs and / or H2 receptor blockers in the month prior to enrollment for clinical study.
  • Are pregnant or lactating.
  • Have intestinal obstruction, gastrointestinal surgery in the last thirty days, *Barrett's esophagus.

    * Make use of reflux stimulating drugs.

  • With Zollinger-Ellison Syndrome,

    * Have active bleeding.

  • Are currently in use or have recently used oral / venous antibiotics (within the last six weeks).

Patients whose biopsy from upper digestive endoscopy is negative for H. pylori will also be excluded.


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): NCT04069286


Contacts
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Contact: JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD 11989780869 jancarlo@hebron.com.br
Contact: Haliny Magalhães, Pharm. B. haliny@hebron.com.br

Sponsors and Collaborators
Infan Industria Quimica Farmaceutica Nacional
Hospital Universitário Oswaldo Cruz
Investigators
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Principal Investigator: Severino B Santos, PhD Hospital Univeristário Oswaldo Cruz

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Responsible Party: Infan Industria Quimica Farmaceutica Nacional
ClinicalTrials.gov Identifier: NCT04069286     History of Changes
Other Study ID Numbers: HB/F3-001/2018
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Omeprazole
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action