S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori)
This study has been completed.
Sponsor:
Southwest Oncology Group
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
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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
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 Gram-Negative Bacterial Infections Bacterial Infections Anti-Bacterial Agents Lansoprazole Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013