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NCT Number: NCT01967329

CANHelp Working Group Treatment Trials

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

About this study

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:

  • Estimate the effectiveness of alternate H. pylori treatment regimens to identify optimal regimens for the local setting
  • Identify factors external to the treatment regimen that influence short- and long-term treatment success

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Triple

Drug

Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg)

Other names: Standard Triple Therapy for H. pylori, Hp-PAC

Sequential

Drug

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)

Other names: Sequential Therapy for H. pylori

Quadruple

Drug

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

Other names: Quadruple Therapy for H. pylori

Primary outcomes

  1. Post-treatment H. pylori status by urea breath test

    Time frame: A minimum of 10 weeks after participant has completed treatment

    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)

Secondary outcomes

  1. Adherence to treatment regimen

    Time frame: An expected average of 1 week after treatment is completed

    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.

Other outcomes

  1. Frequency of adverse effects

    Time frame: From the time treatment is started to an expected average of 1 week after treatment is completed

    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.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions
  • ArcticNet
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2013
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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