Helicobacter Pylori InfectionPhase 4NCT01967329
CANHelp Working Group Treatment Trials
A Phase 4 study testing Standard Triple, Sequential and Quadruple in people with Helicobacter Pylori Infection, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Standard Triple, Sequential and Quadruple
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Canadian North Helicobacter Pylori (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.
Read the 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:
- 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
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Standard Triple, Sequential, Quadruple
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard TripleDrug
Also called Standard Triple Therapy for H. pylori, Hp-PAC
Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg)
SequentialDrug
Also called 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)
QuadrupleDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Quadruple |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: A minimum of 10 weeks after participant has completed treatment
Secondary outcomes (1)
Adherence to treatment regimen
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.
Measured: An expected average of 1 week after treatment is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startNov 2008
- Primary completionMay 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, ArcticNet, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Karen Goodman, University of Alberta
- Investigators
- Karen Goodman, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967329
- Sponsor's protocol ID
- Pro00007868
- Status last verified
- Sep 2019
- First submitted
- 9 Oct 2013
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: No plan to make individual participant data (IPD) available
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials
- ClinicalTrials.gov ID
- NCT01967329
- Acronym / sponsor ID
- Pro00007868
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, ArcticNet, Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2008
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Standard Triple, treatment naive | Active comparator | Drug: Standard TripleStandard 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 | Drug: SequentialSequential 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 | Drug: QuadrupleQuadruple 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 | Drug: SequentialSequential 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 | Drug: QuadrupleQuadruple 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 | Drug: SequentialSequential 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 | Drug: QuadrupleQuadruple 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TripleAlso: Standard Triple Therapy for H. pylori, Hp-PACOral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg) | Drug | Standard Triple, treatment naive |
| SequentialAlso: Sequential Therapy for H. pyloriOral 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) | Drug | Sequential, clarithromycin-resistant, Sequential, previous failure(s), Sequential, treatment naive |
| QuadrupleAlso: Quadruple Therapy for H. pyloriOral 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 | Drug | Quadruple, clarithromycin-resistant, Quadruple, previous failure(s), Quadruple, treatment naive |
Primary outcome
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)
1 secondary outcome
Adherence to treatment regimen
Time frame: An expected average of 1 week after treatment is completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Canadian North Helicobacter pylori (CANHelp) Working Group websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. No plan to make individual participant data (IPD) available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Goodman, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Triple, Sequential and Quadruple in people with Helicobacter Pylori Infection, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-treatment H. pylori status by urea breath test (time frame: A minimum of 10 weeks after participant has completed treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.