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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01061437
• Other study ID #: S0701
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2010
• Last updated: September 24, 2012
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2012
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1859
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• PACx14
Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)
• PACMx5
Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)
• 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)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

Chile,  Colombia,  Costa Rica,  Honduras,  Mexico,  Nicaragua, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare 2 experimental antibiotic regimens with a standard 14 day regimen with regard to H. pylori eradication rates at 6 weeks post-randomization.		week 6 post-randomization	Yes
Secondary	Secondary aims will examine infection rates at 1 year, safety and tolerability of these regimens,& potential differential effects among selected groups.		1 year	Yes

External Links

•   Click here for more information about the study: S0701, "A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori."