Trial | NCT01967329  Report issue

Title

CANHelp Working Group Treatment Trials
Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    338
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.
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
Study Started
Nov 30
2008
Primary Completion
May 31
2019
Study Completion
May 31
2019
Last Update
Sep 26
2019

Drug Standard Triple

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

Drug 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)

  • Other names: Sequential Therapy for H. pylori

Drug 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

  • Other names: Quadruple Therapy for H. pylori

Standard Triple, treatment naive Active Comparator

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

Sequential, treatment naive Active Comparator

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

Quadruple, treatment naive Active Comparator

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

Sequential, previous failure(s) Active Comparator

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

Quadruple, previous failure(s) Active Comparator

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

Sequential, clarithromycin-resistant Active Comparator

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

Quadruple, clarithromycin-resistant Active Comparator

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

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
No Results Posted