Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

March 17, 2015 updated by: Jorge Escobedo de la Pena, Coordinación de Investigación en Salud, Mexico

Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequential therapy
Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
Drug: Sequential therapy
Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
Other Names:
  • Omeprazole-Amoxicillin-Clarithromycin-Metronidazole
Active Comparator: Triple therapy
Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days
Drug: Triple therapy
Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days
Other Names:
  • Omeprazole-Clarithromycin-Metronidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication
Time Frame: 6 to 8 week after treatment
Helicobacter pylori in gastric biopsy
6 to 8 week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: two weeks after beginning of treatment
Nausea, vomiting, stomach ache
two weeks after beginning of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

March 17, 2015

First Posted (Estimate)

March 23, 2015

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2013-3609-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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