Helicobacter Pylori InfectionPhase 4NCT02490839
Efficacy of High-dose Dual Therapy vs Bismuth-containing Quadruple Therapy for Rescue Treatment of Hp Infection
A Phase 4 study testing High-dose dual therapy (rabeprazole, amoxicillin) and Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication. The aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- High-dose dual therapy (rabeprazole, amoxicillin) and Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2015to Jan 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.
Who cannot join
- pregnant or nursing woman
- serious concomitant illness and malignant tumor of any kind
- history of hypersensitivity to test drugs
- serious bleeding during the course of the ulcer
- previous gastric surgery
- receiving bismuth salts, PPIs, or antibiotics in the previous month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study
Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication.
The aims of this study are:
- to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;
- to compare the patient adherence and adverse effects of these treatment regimens;
- to investigate factors that may influence H. pylori eradication by these treatment regimens.
Read the detailed description
Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.
If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:
group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);
group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);
All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- High-dose dual therapy (rabeprazole, amoxicillin), Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)
- Keywords
- Helicobacter pylori, high dose dual therapy, bismuth-containing quadruple therapy, antibiotic resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose dual therapy (rabeprazole, amoxicillin)Drug
Also called Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®
High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)Drug
Also called Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Metronidazole, Flagyl®, Antibiotics, Tetracycline, Tetracycline®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®
Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)
| Study group | Role | What they receive |
|---|---|---|
| High-dose dual therapy | Experimental | group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days) Receives: Drug: High-dose dual therapy (rabeprazole, amoxicillin) |
| Bismuth-containing quadruple therapy | Active comparator | group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days) Receives: Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rates as a measure of the efficacy of HDDT, and BQT
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: 3.5 years
Secondary outcomes (2)
Number of participants with adverse effects as a measure of safety
The safety will be evaluated by counting the number of participant with adverse events.
Measured: 3.5 years
Amount of unused medication post treatment as a measure of patient adherence.
The patient adherence will be evaluated by counting unused medication after the treatment.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2018
- Study completionJan 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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyh-Chin Yang, M.D.Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490839
- Sponsor's protocol ID
- 201504037MINB
- Status last verified
- Apr 2020
- First submitted
- 2 Jul 2015
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-dose Dual Therapy Versus Bismuth-containing Quadruple Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective, Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT02490839
- Acronym / sponsor ID
- 201504037MINB
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, high dose dual therapy, bismuth-containing quadruple therapy, antibiotic resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 7 Jul 2015 (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.
Up to now, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of high-dose dual therapy (HDDT) and bismuth-containing quadruple therapy (BQT) as rescue regimens for H. pylori eradication.
The aims of this study are:
- to compare the efficacy of HDDT, and BQT as rescue regimen in H. pylori eradication;
- to compare the patient adherence and adverse effects of these treatment regimens;
- to investigate factors that may influence H. pylori eradication by these treatment regimens.
Detailed description
Participants, aged ≥ 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. All undergo endoscopy with biopsy for rapid urease teat, histology, and bacterial culture before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test. The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymerase (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A, and B.
If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens. Participant who meet the inclusion criteria and do not have any one of the exclusion criteria will be randomized to receive one of the following regimens:
group A- HDDT (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days);
group B- BQT ( rabeprazole 20 mg qid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days);
All participants will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the participants will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effect of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose dual therapy | Experimental | Drug: High-dose dual therapy (rabeprazole, amoxicillin)group A-high-dose dual therapy ( rabeprazole 20 mg, tablet, qid + amoxicillin 750 mg, capsule, qid for 14 days) |
| Bismuth-containing quadruple therapy | Active comparator | Drug: Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)group B-bismuth-containing quadruple therapy (rabeprazole 20 mg, tablet, bid + tripotassium dicitrate bismuthate 300 mg, tablet, qid + metronidazole 250 mg, tablet, qid + tetracycline 500 mg qid, capsule, for 10 days) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 20 years old and are willing to received eradication therapy.
Key exclusion criteria (6 listed)
- pregnant or nursing woman
- serious concomitant illness and malignant tumor of any kind
- history of hypersensitivity to test drugs
- serious bleeding during the course of the ulcer
- previous gastric surgery
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 |
|---|---|---|
| High-dose dual therapy (rabeprazole, amoxicillin)Also: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Amoxicillin ,Amoxicillin®High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days) | Drug | High-dose dual therapy |
| Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)Also: Proton pump inhibitor, Rabeprazole, Pariet®, Antibiotics, Metronidazole, Flagyl®, Antibiotics, Tetracycline, Tetracycline®, Colloidal Bismuth, Tripotassium dicitrate bismuthate, KCB®Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days) | Drug | Bismuth-containing quadruple therapy |
Primary outcome
The eradication rates as a measure of the efficacy of HDDT, and BQT
Time frame: 3.5 years
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
2 secondary outcomes
Number of participants with adverse effects as a measure of safety
Time frame: 3.5 years
Amount of unused medication post treatment as a measure of patient adherence.
Time frame: 3.5 years
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 29 Apr 2020.
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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.
Jyh-Chin Yang, M.D.Ph.D. principal investigator
National Taiwan University Hospital
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 High-dose dual therapy (rabeprazole, amoxicillin) and Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline) in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 6 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 29 Apr 2020. 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 Taiwan. 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?
The eradication rates as a measure of the efficacy of HDDT, and BQT (time frame: 3.5 years). 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 29 Apr 2020.