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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01061437
First received: February 1, 2010
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
Helicobacter Pylori Infection
Drug: PACx14
Drug: PACMx5
Drug: PAx5/PCMx5
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1859
Study Start Date: June 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Standard 14 day, 3-drug regimen
Drug: PACx14
Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
Other Name: 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 Name: 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 Name: Lansoprazole: Prevacid

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).

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061437

Locations
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Colombia
Universidad del Valle
Cali, Valle, Colombia
Costa Rica
Fundacion Inciensa
San Jose, Costa Rica
Honduras
Hospital Occidente
Copan, Honduras
Mexico
National Institute for Public Health
Cuernavaca, Morelos, Mexico
Instituto Technologico de Sonora
Obregon, Sonora, Mexico
Nicaragua
Centro de Investigacion en Demografia y Salud de la Iglesia Merced
Leon, Nicaragua
Sponsors and Collaborators
Southwest Oncology Group
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: E. Robert Greenberg, M.D. Southwest Oncology Group
  More Information

Additional Information:
No publications provided by Southwest Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01061437     History of Changes
Other Study ID Numbers: S0701
Study First Received: February 1, 2010
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southwest Oncology Group:
H. pylori

Additional relevant MeSH terms:
Helicobacter Infections
Bacterial Infections
Gram-Negative Bacterial Infections
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014