CANHelp Working Group Treatment Trials

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Sequential; Drug: Quadruple; Drug: Standard Triple

Study type: Interventional

Funder types: Other

Identifiers

NCT01967329

Pro00007868

Details and patient eligibility

About

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.

Full 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

Enrollment: 338 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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338 participants in 7 patient groups

Standard Triple, treatment naive

Active Comparator group

Description:

Standard Triple Therapy for H. pylori: Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg) One of two treatments randomly assigned to treatment naive participants in Aklavik

Treatment:

Drug: Standard Triple

Sequential, treatment naive

Active Comparator group

Description:

Sequential Therapy for H. pylori: 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) One of two treatments randomly assigned to treatment naive participants in Aklavik, Old Crow, Tuktoyaktuk \& Fort McPherson

Treatment:

Drug: Sequential

Quadruple, treatment naive

Active Comparator group

Description:

Quadruple Thearpy for H. pylori: 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 One of two treatments randomly assigned to treatment naive participants in Old Crow, Tuktoyaktuk \& Fort McPherson

Treatment:

Drug: Quadruple

Sequential, previous failure(s)

Active Comparator group

Description:

Sequential Therapy for H. pylori: 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) One of two treatments randomly assigned to participants who previously failed one or more treatments in Aklavik, Old Crow, Tuktoyaktuk \& Fort McPherson

Treatment:

Drug: Sequential

Quadruple, previous failure(s)

Active Comparator group

Description:

Quadruple Therapy for H. pylori: 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 One of two treatments randomly assigned to participants who previously failed treatment in Aklavik, Old Crow, Tuktoyaktuk \& Fort McPherson

Treatment:

Drug: Quadruple

Sequential, clarithromycin-resistant

Active Comparator group

Description:

Sequential Therapy for H. pylori: 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) One of two treatments randomly assigned to participants with known clarithromycin resistance in Aklavik

Treatment:

Drug: Sequential

Quadruple, clarithromycin-resistant

Active Comparator group

Description:

Quadruple Therapy for H. pylori: 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 One of two treatments randomly assigned to participants with known clarithromycin resistance in Aklavik

Treatment:

Drug: Quadruple