Helicobacter Pylori InfectionPhase 4NCT01265069
Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy
A Phase 4 study testing high dose dual therapy and concomitant therapy in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- high dose dual therapy and concomitant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Dec 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.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10043
Jyh-Chin Yang, M.D.Ph.D., 886-2-23123456 ext. 65055, jcyang47@ntu.edu.tw
About this study
Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.
The aims of this study are:
- to compare the efficacy of high dose dual therapy and concomitant 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.
Read the detailed description
Patients, aged 18, 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 two subgroups, say A and B.
If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:
group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).
All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient Clinic to investigate patient adherence and adverse effects of treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- high dose dual therapy, concomitant therapy
- Keywords
- Helicobacter pylori, concomitant therapy, high dose dual 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 therapyDrug
rabeprazole 20mg qid,amoxicillin 750mg qid for 14days
concomitant therapyDrug
rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days
| Study group | Role | What they receive |
|---|---|---|
| high dose dual therapy | Active comparator | Group A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days) Receives: Drug: high dose dual therapy |
| concomitant therapy | Experimental | Group B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 days). Receives: Drug: concomitant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
Measured: 1.5 years
Secondary outcomes (1)
to compare the adverse effects and patient adherence of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy
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 and record symptoms in a diary card).
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
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
- 204 participants (estimated)
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
- NCT01265069
- Sponsor's protocol ID
- 201005064M
- Status last verified
- May 2013
- First submitted
- 10 Dec 2010
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy
- ClinicalTrials.gov ID
- NCT01265069
- Acronym / sponsor ID
- 201005064M
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, concomitant therapy, high dose dual therapy, antibiotic resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2010
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Dec 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.
Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.
The aims of this study are:
- to compare the efficacy of high dose dual therapy and concomitant 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.
Detailed description
Patients, aged 18, 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 two subgroups, say A and B.
If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:
group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).
All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient 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
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose dual therapy | Active comparator | Drug: high dose dual therapyGroup A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days) |
| concomitant therapy | Experimental | Drug: concomitant therapyGroup B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 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 20mg qid,amoxicillin 750mg qid for 14days | Drug | high dose dual therapy |
| concomitant therapyrabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days | Drug | concomitant therapy |
Primary outcome
to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy
Time frame: 1.5 years
The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
1 secondary outcome
to compare the adverse effects and patient adherence of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
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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 and concomitant therapy 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: status not confirmed, as of the sponsor's last update on 3 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Chin Yang, M.D.Ph.D (886-2-23123456 ext. 65055, jcyang47@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy (time frame: 1.5 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 3 Jun 2013.