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

NCT01061437 | Completed Phase 3 DMC

• 1 other identifier: S0701
• Study Type: interventional
• Target: 1,859
• Locations: 5 countries
• Sites: 6

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Keywords

H. pylori

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  1 year

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Standard 14 day, 3-drug regimen

Drug: PACx14

Arm 2

EXPERIMENTAL

Concomitant Therapy - 5 day, 4-drug regimen

Drug: PACMx5

Arm 3

EXPERIMENTAL

Sequential Therapy - 10 day, 4-drug regimen

Drug: PAx5/PCMx5

Interventions

PACx14 DRUG

Standard 14 day, 3 drug regimen: lansoprazole, amoxicillin, clarithromycin (PACx14)

Also known as: Lansoprazole: Prevacid

Arm 1

PACMx5 DRUG

Concomitant therapy - 5 day, 4 drug regimen: lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5)

Also known as: Lansoprazole: Prevacid

Arm 2

PAx5/PCMx5 DRUG

Sequential Therapy - 10 day, 4-drug regimen: lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5)

Also known as: Lansoprazole: Prevacid

Arm 3

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (7)

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Universidad del Valle

Cali, Valle del Cauca Department, Colombia

Location

Fundacion Inciensa

San José, Costa Rica

Location

Hospital Occidente

Copán, Honduras

Location

National Institute for Public Health

Cuernavaca, Morelos, Mexico

Location

Instituto Technologico de Sonora

Obregón, Sonora, Mexico

Location

Centro de Investigacion en Demografia y Salud de la Iglesia Merced

León, Nicaragua

Location

Related Publications (2)

• Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martinez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Pena EM, Pena R, Correa P, Martinez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH. Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities. JAMA. 2013 Feb 13;309(6):578-86. doi: 10.1001/jama.2013.311.

  PMID: 23403682 DERIVED

• Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Pena R, Pena EM, Salazar-Martinez E, Correa P, Martinez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet. 2011 Aug 6;378(9790):507-14. doi: 10.1016/S0140-6736(11)60825-8. Epub 2011 Jul 21.

  PMID: 21777974 DERIVED

Related Links

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

MeSH Terms

Interventions

Lansoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• E. Robert Greenberg, M.D.

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 3, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

CO (1); CL (1); ME (2); NI (1); HO (1)