search
Back to results

Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Primary Purpose

Helicobacter Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sequential therapy
Triple therapy
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Infections focused on measuring Sequential therapy, Triple therapy, Eradication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Helicobacter pylori infection in biopsy
  • Eradication required

Exclusion Criteria:

  • Antibiotic received two weeks prior
  • Previous treatment for H pylori infection
  • Allergy to any of the treatment drugs
  • Smoking > 5 cigarettes daily.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sequential therapy

    Triple therapy

    Arm Description

    Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days

    Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days

    Outcomes

    Primary Outcome Measures

    Eradication
    Helicobacter pylori in gastric biopsy

    Secondary Outcome Measures

    Side effects
    Nausea, vomiting, stomach ache

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    March 17, 2015
    Sponsor
    Coordinación de Investigación en Salud, Mexico
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02395458
    Brief Title
    Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
    Official Title
    Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Coordinación de Investigación en Salud, Mexico

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.
    Detailed Description
    In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Helicobacter Infections
    Keywords
    Sequential therapy, Triple therapy, Eradication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    142 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sequential therapy
    Arm Type
    Experimental
    Arm Description
    Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
    Arm Title
    Triple therapy
    Arm Type
    Active Comparator
    Arm Description
    Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Sequential therapy
    Other Intervention Name(s)
    Omeprazole-Amoxicillin-Clarithromycin-Metronidazole
    Intervention Description
    Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    Triple therapy
    Other Intervention Name(s)
    Omeprazole-Clarithromycin-Metronidazole
    Intervention Description
    Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days
    Primary Outcome Measure Information:
    Title
    Eradication
    Description
    Helicobacter pylori in gastric biopsy
    Time Frame
    6 to 8 week after treatment
    Secondary Outcome Measure Information:
    Title
    Side effects
    Description
    Nausea, vomiting, stomach ache
    Time Frame
    two weeks after beginning of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Helicobacter pylori infection in biopsy Eradication required Exclusion Criteria: Antibiotic received two weeks prior Previous treatment for H pylori infection Allergy to any of the treatment drugs Smoking > 5 cigarettes daily.

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

    We'll reach out to this number within 24 hrs