Helicobacter InfectionPhase 4NCT01163435
Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication
A Phase 4 study testing high dose dual therapy, sequential therapy and clarithromycin-based triple therapy in people with Helicobacter Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country. The aims of this study are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Infection
- What is being tested?
- high dose dual therapy, sequential therapy and clarithromycin-based triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2010to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years 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 this ulcer
- previous gastric surgery
- receiving bismuth salts, proton pump inhibitors, 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, Sequential Therapy and Triple Therapy in H. Pylori Eradication - A Prospective, Comparative Study
Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country.
The aims of this study are:
- to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;
- to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy 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;
- to investigate and analyze the prevalence and trend of antibiotic resistance.
Read the detailed description
Patients having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP) 2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into three subgroups, say A1, B1 and C1 (or A2, B2, and C2).
If the patients did not receive anti-H. pylori therapy previously, they will be invited to enter the first part of study for evaluating the efficacy of 1st-line regimens. If the patients had received anti-H. pylori therapy previously, they will be invited to enter the second part of study for evaluating the efficacy of rescue regimens. Patients 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:
- for 1st-line regimens: group A1 - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B1 - sequential therapy (rabeprazole 20 mg + amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for next 5 days); group C1 - clarithromycin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg, bid for 7 days).
- for rescue regimens: group A2 - high dose dual therapy (as group A1); group B2 - sequential therapy (as group B1); group C2 - levofloxacin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + levofloxacin 250 mg, bid for 7 days).
All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the patients were seen at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment.
- Conditions
- Helicobacter Infection
- Being tested
- high dose dual therapy, sequential therapy, clarithromycin-based triple therapy, levofloxacin-based triple therapy
- Keywords
- Helicobacter pylori, antibiotic resistance, high dose dual therapy, sequential therapy, clarithromycin-based triple therapy, levofloxacin-based triple therapy
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high dose dual therapyDrug
rabeprazole 20 mg qid,amoxicillin 750 mg qid for 14 days
sequential therapyDrug
rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days
clarithromycin-based triple therapyDrug
rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days
levofloxacin-based triple therapyDrug
rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days
| Study group | Role | What they receive |
|---|---|---|
| high dose dual therapy | Experimental | group A1 and A2 - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days) Receives: Drug: high dose dual therapy |
| sequential therapy | Experimental | group B1 and B2 - sequential therapy (rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days) Receives: Drug: sequential therapy |
| clarithromycin-based triple therapy | Active comparator | group C1 - clarithromycin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days) Receives: Drug: clarithromycin-based triple therapy |
| levofloxacin-based triple therapy | Active comparator | group C2 - levofloxacin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days) Receives: Drug: levofloxacin-based triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the efficacy, adverse effects and patient adherence of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy (or levofloxacin-based triple therapy) as 1st-line regimen (or rescue regimen) in H. pylori eradication
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. The safety and tolerability will be evaluated by the number of participant with adverse events and patient adherence (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 posted15 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter 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
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jyh-Chin Yang, M.D.Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163435
- Sponsor's protocol ID
- 200912093M
- Status last verified
- Dec 2013
- First submitted
- 1 Jul 2010
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang JC, Lin CJ, Wang HL, Chen JD, Kao JY, Shun CT, Lu CW, Lin BR, Shieh MJ, Chang MC, Chang YT, Wei SC, Lin LC, Yeh WC, Kuo JS, Tung CC, Leong YL, Wang TH, Wong JM. High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2015 May;13(5):895-905.e5. doi: 10.1016/j.cgh.2014.10.036. Epub 2014 Nov 14.
PubMed 25460556
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication - A Prospective, Comparative Study
- ClinicalTrials.gov ID
- NCT01163435
- Acronym / sponsor ID
- 200912093M
- Conditions
- Helicobacter Infection
- Keywords
- Helicobacter pylori, antibiotic resistance, high dose dual therapy, sequential therapy, clarithromycin-based triple therapy, levofloxacin-based triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2010 (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, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country.
The aims of this study are:
- to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;
- to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy 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;
- to investigate and analyze the prevalence and trend of antibiotic resistance.
Detailed description
Patients having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP) 2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into three subgroups, say A1, B1 and C1 (or A2, B2, and C2).
If the patients did not receive anti-H. pylori therapy previously, they will be invited to enter the first part of study for evaluating the efficacy of 1st-line regimens. If the patients had received anti-H. pylori therapy previously, they will be invited to enter the second part of study for evaluating the efficacy of rescue regimens. Patients 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:
- for 1st-line regimens: group A1 - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B1 - sequential therapy (rabeprazole 20 mg + amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for next 5 days); group C1 - clarithromycin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + clarithromycin 500 mg, bid for 7 days).
- for rescue regimens: group A2 - high dose dual therapy (as group A1); group B2 - sequential therapy (as group B1); group C2 - levofloxacin-based triple therapy (rabeprazole 20 mg + amoxicillin 1000 mg + levofloxacin 250 mg, bid for 7 days).
All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily during the treatment period. Post-treatment, the patients were seen at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high dose dual therapy | Experimental | Drug: high dose dual therapygroup A1 and A2 - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days) |
| sequential therapy | Experimental | Drug: sequential therapygroup B1 and B2 - sequential therapy (rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days) |
| clarithromycin-based triple therapy | Active comparator | Drug: clarithromycin-based triple therapygroup C1 - clarithromycin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days) |
| levofloxacin-based triple therapy | Active comparator | Drug: levofloxacin-based triple therapygroup C2 - levofloxacin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years 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 this 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 therapyrabeprazole 20 mg qid,amoxicillin 750 mg qid for 14 days | Drug | high dose dual therapy |
| sequential therapyrabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days | Drug | sequential therapy |
| clarithromycin-based triple therapyrabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days | Drug | clarithromycin-based triple therapy |
| levofloxacin-based triple therapyrabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days | Drug | levofloxacin-based triple therapy |
Primary outcome
to compare the efficacy, adverse effects and patient adherence of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy (or levofloxacin-based triple therapy) as 1st-line regimen (or rescue regimen) in H. pylori eradication
Time frame: 3.5 years
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. The safety and tolerability will be evaluated by the number of participant with adverse events and patient adherence (by counting unused medication after the treatment).
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 3 Dec 2013.
- Derived from this study: PubMed 25460556Yang JC, Lin CJ, Wang HL, Chen JD, Kao JY, Shun CT, Lu CW, Lin BR, Shieh MJ, Chang MC, Chang YT, Wei SC, Lin LC, Yeh WC, Kuo JS, Tung CC, Leong YL, Wang TH, Wong JM. High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2015 May;13(5):895-905.e5. doi: 10.1016/j.cgh.2014.10.036. Epub 2014 Nov 14.
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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, sequential therapy and clarithromycin-based triple therapy in people with Helicobacter 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 3 Dec 2013. 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?
to compare the efficacy, adverse effects and patient adherence of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy (or levofloxacin-based triple therapy) as 1st-line regimen (or rescue regimen) in H. pylori eradication (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?
On the ClinicalTrials.gov record for NCT01163435, which also lists 1 linked publication.
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 3 Dec 2013.