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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

February 1, 2010
September 24, 2012
June 2009
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01061437 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
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).

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Helicobacter Pylori Infection
  • Drug: PACx14
    Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
    Other Name: Lansoprazole: Prevacid
  • Drug: PACMx5
    Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
    Other Name: Lansoprazole: Prevacid
  • 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
  • Active Comparator: Arm 1
    Standard 14 day, 3-drug regimen
    Intervention: Drug: PACx14
  • Experimental: Arm 2
    Concomitant Therapy - 5 day, 4-drug regimen
    Intervention: Drug: PACMx5
  • Experimental: Arm 3
    Sequential Therapy - 10 day, 4-drug regimen
    Intervention: Drug: PAx5/PCMx5

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1859
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Colombia,   Costa Rica,   Honduras,   Mexico,   Nicaragua
 
NCT01061437
S0701
Yes
Southwest Oncology Group
Southwest Oncology Group
Bill and Melinda Gates Foundation
Principal Investigator: E. Robert Greenberg, M.D. Southwest Oncology Group
Southwest Oncology Group
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP