CANHelp Working Group Treatment Trials

NCT01967329 | Completed Phase 4

• 1 other identifier: Pro00007868
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence to treatment regimen

  An expected average of 1 week after treatment is completed

Other Outcomes (1)

• Frequency of adverse effects

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

Study Arms (7)

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

Drug: Standard Triple

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

Drug: Sequential

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

Drug: Quadruple

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

Drug: Sequential

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

Drug: Quadruple

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

Drug: Sequential

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

Drug: Quadruple

Interventions

Standard Triple DRUG

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

Also known as: Standard Triple Therapy for H. pylori, Hp-PAC

Standard Triple, treatment naive

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)

Also known as: Sequential Therapy for H. pylori

Sequential, clarithromycin-resistant; Sequential, previous failure(s); Sequential, treatment naive

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

Also known as: Quadruple Therapy for H. pylori

Quadruple, clarithromycin-resistant; Quadruple, previous failure(s); Quadruple, treatment naive

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• ArcticNet: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Links

• Canadian North Helicobacter pylori (CANHelp) Working Group website

Study Officials

• Karen Goodman, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 22, 2013
• Study Start: November 1, 2008
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)