S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)

September 24, 2012 updated by: Southwest Oncology Group

A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).

Study Type

Interventional

Enrollment (Actual)

1859

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile
  • Colombia
    • Valle
      • Cali, Valle, Colombia
        • Universidad del Valle
  • Costa Rica
      • San Jose, Costa Rica
        • Fundación Inciensa
  • Honduras
      • Copan, Honduras
        • Hospital Occidente
  • Mexico
    • Morelos
      • Cuernavaca, Morelos, Mexico
        • National Institute for Public Health
    • Sonora
      • Obregon, Sonora, Mexico
        • Instituto Technologico de Sonora
  • Nicaragua
      • Leon, Nicaragua
        • Centro de Investigacion en Demografia y Salud de la Iglesia Merced

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • positive Urea Breath Test documenting H. pylori infection
  • age 21 - 65 years
  • no known allergies to study drugs
  • only member of household participating in study
  • no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy
  • patients must be willing to discontinue alcohol use for 15 days (maximum duration of treatment plus one day)
  • patients must be willing to discontinue use of antacids for duration of study treatment
  • patients must not have used proton pump inhibitors (PPI) within 30 days of registration. Patients also must be willing to stop using non-study provided PPIs until the completion of the 6 week follow-up contact.
  • patients must not have been treated with antibiotics for H. pylori in the past and must not have taken any other antibiotics within 30 days of registration.
  • patients must be willing to return for 2 follow-up visits: 6 weeks after randomization following completion of treatment & 1 year after randomization
  • patients must be willing to allow submission of blood for assays of serum markers of bacterial virulence and host genetic susceptibility and environmental factors and provide consent for use of specimens.

Exclusion Criteria:

  • current use of anti-retroviral therapy for HIV or AIDS
  • diagnosed congestive hear failure
  • renal failure requiring dialysis
  • diagnosed hepatic failure resulting in hyperbilirubinemia
  • any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years
  • pregnancy or nursing mothers

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
Active Comparator: Arm 1
Standard 14 day, 3-drug regimen
Drug: PACx14
Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
Other Names:
  • Lansoprazole: Prevacid
Experimental: Arm 2
Concomitant Therapy - 5 day, 4-drug regimen
Drug: PACMx5
Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
Other Names:
  • Lansoprazole: Prevacid
Experimental: Arm 3
Sequential Therapy - 10 day, 4-drug regimen
Drug: PAx5/PCMx5
Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)
Other Names:
  • Lansoprazole: Prevacid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.
Time Frame: week 6 post-randomization
week 6 post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: E. Robert Greenberg, M.D., Southwest Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

June 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

September 26, 2012

Last Update Submitted That Met QC Criteria

September 24, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S0701

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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