CANHelp Working Group Treatment Trials

Helicobacter Pylori Infection Clinical Trial

Official title:

Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967329
• Other study ID #: Pro00007868
• Status: Completed
• Phase: Phase 4
• Start date: November 2008
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Description:

The CANHelp Working Group is a collaborative team that links University of Alberta researchers with Canadian northern community leaders and health officials in a collaborative effort to investigate H. pylori infection with the goal of finding solutions to community concerns about health risks. The research program uses a community-driven research approach in northern communities to characterize the burden of disease from H. pylori infection and exchange knowledge with community members and decision makers to identify ways to reduce health risks from this infection.

For the participating communities, the 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Standard Triple
Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg)
• Sequential
Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg)
• Quadruple
Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions, ArcticNet, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of adverse effects	Participants are contacted by telephone during the completion of the treatment regimen and asked if they have experienced adverse effects. Participants are also interviewed immediately after the completion of treatment and asked if they experienced adverse effects during the completion of treatment.	From the time treatment is started to an expected average of 1 week after treatment is completed
Primary	Post-treatment H. pylori status by urea breath test	Treatment effectiveness, defined as the probability (average risk) of elimination of H. pylori infection following treatment, measured as the proportion of trial participants with a negative post-treatment urea breath test at least 10 weeks following completion of treatment. Using an intention-to-treat analysis, the denominator for this proportion is the number of trial participants assigned treatment. Using a per-protocol analysis, the denominator for this proportion is the number of trial participants who completed treatment and were tested post-treatment.; Participants are administered a urea breath test using 13C-labeled urea dissolved in a citric acid solution. We use the following test value classifications for determining the outcome: >=4.0 (Positive for H. pylori infection) Between 2.5 and 4.0 (Borderline; repeat test) Between 2.4 and -1.99 (Negative for H. pylori infection) Less than -2.0 (Uncertain test result, repeat test)	A minimum of 10 weeks after participant has completed treatment
Secondary	Adherence to treatment regimen	Participants are asked to return blister packs with unused medication so skipped doses can be counted. Participants are also interviewed to obtain details about their adherence to the regimen.	An expected average of 1 week after treatment is completed

External Links

•   Canadian North Helicobacter pylori (CANHelp) Working Group website