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HEPRA: 14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

Sponsor
mohamed bouchoucha (Industry)
Overall Status
Completed
CT.gov ID
NCT04769583
Collaborator
(none)
121
Enrollment
1
Location
2
Arms
12.8
Actual Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

Condition or Disease Intervention/Treatment Phase
  • Drug: metronidazole based quadriple therapy
  • Drug: placebo based quadriple therapy
 Phase 4

Detailed Description

This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.

The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

  1. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
a placebo which has the same visual characteristics as metronidazole in the boxes of the triple therapy
Primary Purpose:
Treatment
Official Title:
A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
Actual Study Start Date :
Feb 10, 2019
Actual Primary Completion Date :
Feb 17, 2020
Actual Study Completion Date :
Mar 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: concomitant quadruple therapy (QC)

PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days

Drug: metronidazole based quadriple therapy
patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)
Other Names:
  • concomitant quadruple therapy (QC)

    		•
    Placebo Comparator: triple therapy (TT)

    PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days.

    Drug: placebo based quadriple therapy
    patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.
    Other Names:
  • Triple therapy (TT)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HP eradiction rate [6 weeks after completion of study treatment]

      assessment by breath test

    Secondary Outcome Measures

    1. percentage of adverse reactions [3 months]

      we will determinate the percentage of adverse reactions in each group of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients aged between 18 and 65, with documented Hp infection.
    Exclusion Criteria: are excluded patients:

    • With Cirrhosis.

    • With Renal failure (serum creatinine> 120 µmol / L).

    • Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.

    • Having severe psychiatric disorders.

    • Having had gastric surgery in their history.

    • Having already received an HP eradication treatment.

    • Having received an antibiotic within the last two weeks.

    • Who are allergic to one of the antibiotics used in the anti-Hp cure.

    • Who are drug addicted.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fattouma Bourguiba Hospital Monastir Tunisia

    Sponsors and Collaborators

    • mohamed bouchoucha

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohamed bouchoucha, Assistant Clinical Data management, Les Laboratoires des Médicaments Stériles
    ClinicalTrials.gov Identifier:
    NCT04769583
    Other Study ID Numbers:
    • TN2018-INT-INS-14
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by mohamed bouchoucha, Assistant Clinical Data management, Les Laboratoires des Médicaments Stériles
    Breath Tests
    Helicobacter pylori
    Additional relevant MeSH terms:
    Gastritis
    Metronidazole

    Study Results

    No Results Posted as of Feb 24, 2021