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CANHelp Working Group Treatment Trials

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ClinicalTrials.gov Identifier: NCT01967329
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2013
Last Update Posted : May 17, 2019
Sponsor:
Collaborators:
Alberta Innovates Health Solutions
ArcticNet
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Karen Goodman, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Standard Triple Drug: Sequential Drug: Quadruple Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials
Study Start Date : November 2008
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Active Comparator: Standard Triple, treatment naive

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
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

Active Comparator: Sequential, treatment naive

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
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 Name: Sequential Therapy for H. pylori

Active Comparator: Quadruple, treatment naive

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
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 Name: Quadruple Therapy for H. pylori

Active Comparator: Sequential, previous failure(s)

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
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 Name: Sequential Therapy for H. pylori

Active Comparator: Quadruple, previous failure(s)

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
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 Name: Quadruple Therapy for H. pylori

Active Comparator: Sequential, clarithromycin-resistant

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
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 Name: Sequential Therapy for H. pylori

Active Comparator: Quadruple, clarithromycin-resistant

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
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 Name: Quadruple Therapy for H. pylori




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967329


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
ArcticNet
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Karen Goodman, PhD University of Alberta

Additional Information:
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Responsible Party: Karen Goodman, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01967329     History of Changes
Other Study ID Numbers: Pro00007868
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: No plan to make individual participant data (IPD) available

Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Rabeprazole
Helicobacter Infections
Amoxicillin
Metronidazole
Clarithromycin
Tetracycline
Bismuth
Bismuth subsalicylate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids
Antidiarrheals