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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

Page last updated: August 23, 2015

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