CANHelp Working Group Treatment Trials
Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Pylori Infection
Intervention: Standard Triple (Drug); Sequential (Drug); Quadruple (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: University of Alberta Official(s) and/or principal investigator(s): Karen Goodman, PhD, Principal Investigator, Affiliation: University of Alberta
Summary
The CANHelp Working Group Treatment Trials are part of a comprehensive research program
carried out by the Canadian North Helicobacter pylori (CANHelp) Working Group, a
collaborative team that links University of Alberta investigators with northern Canadian
health authorities and community organizations. This research program uses a
community-driven, participatory approach to investigate H. pylori infection in northern
Aboriginal communities, with goals of characterizing the associated burden of disease and
exchanging knowledge with community members and decision makers to identify effective
solutions for reducing associated health risks. The treatment component involves a series of
community-specific trials designed with community input and varying on the specific
treatment regimens and number of treatment arms among other study details. For the
participating communities, these treatment trials aim to:
1. Estimate the effectiveness of alternate H. pylori treatment regimens to identify
optimal regimens for the local setting
2. Identify factors external to the treatment regimen that influence short- and long-term
treatment success
Clinical Details
Official title: Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Post-treatment H. pylori status by urea breath test
Secondary outcome: Adherence to treatment regimen
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Over 15 years of age
- Identified as H. pylori infected with a positive urea breath test and/or biopsy-based
evidence of H. pylori infection
Exclusion Criteria:
- Allergy to amoxicillin, metronidazole or clarithromycin
- Antibiotic therapy within 4 weeks prior to randomization
- Pregnant or breastfeeding
- Severe cardio-respiratory, pulmonary, endocrine, hepatic or renal disease
Locations and Contacts
University of Alberta, Edmonton, Alberta T6G 2E1, Canada
Additional Information
Canadian North Helicobacter pylori (CANHelp) Working Group website
Starting date: November 2008
Last updated: January 8, 2015
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