Helicobacter Pylori InfectionPhase 4NCT01573975
Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori
A Phase 4 study testing 5RA-5RCM, 5RA-5RCT and 10RCA in people with Helicobacter Pylori Infection, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 5RA-5RCM, 5RA-5RCT and 10RCA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to May 2011
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient proved with infection of H. pylori in gastric mucosa
- adult with signed inform consent
Who cannot join
- woman in breast feeding or pregnancy.
- allergy to drugs used in study.
- three months without use of any antibiotic agents.
- patients under 20 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori
The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.
Read the detailed description
Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.
Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.
Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- 5RA-5RCM, 5RA-5RCT, 10RCA
- Keywords
- Helicobacter pylori, antibiotic resistance, sequential therapy, Taiwan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5RA-5RCMDrug
Also called Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Flagyl x last 5 days
rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.
5RA-5RCTDrug
Also called Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Acromycin x last 5 days.
rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.
10RCADrug
Also called Pariet x 10 days, Klaricid x 10 days, Hiconcil x 10 days.
rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Seq-Metronidazole | Experimental | 10-day sequential therapy with metronidazole Receives: Drug: 5RA-5RCM |
| Seq-Tetracycline | Experimental | 10-day sequential therapy with tetracycline. Receives: Drug: 5RA-5RCT |
| Control | Active comparator | 10-day standard triple therapy. Receives: Drug: 10RCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment
Measured: 4 weeks after complete use of drug for treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Cheh Chen, Buddhist Tzu Chi General Hospital
- Investigators
- Ming-Cheh CHEN, MD, Principal investigator, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573975
- Sponsor's protocol ID
- IRB097-76
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Graham DY, Abudayyeh S, El-Zimaity HM, Hoffman J, Reddy R, Opekun AR. Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Sep 1;24(5):845-50. doi: 10.1111/j.1365-2036.2006.03072.x.
PubMed 16918889Jafri NS, Hornung CA, Howden CW. Meta-analysis: sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 Jun 17;148(12):923-31. doi: 10.7326/0003-4819-148-12-200806170-00226. Epub 2008 May 19.
PubMed 18490667Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. doi: 10.7326/0003-4819-146-8-200704170-00006.
PubMed 17438314Choi WH, Park DI, Oh SJ, Baek YH, Hong CH, Hong EJ, Song MJ, Park SK, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. [Effectiveness of 10 day-sequential therapy for Helicobacter pylori eradication in Korea]. Korean J Gastroenterol. 2008 May;51(5):280-4. Korean.
PubMed 18516011
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT01573975
- Acronym / sponsor ID
- IRB097-76
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, antibiotic resistance, sequential therapy, Taiwan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Apr 2012 (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 purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.
Detailed description
Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide.
Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people.
Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Seq-Metronidazole | Experimental | Drug: 5RA-5RCM10-day sequential therapy with metronidazole |
| Seq-Tetracycline | Experimental | Drug: 5RA-5RCT10-day sequential therapy with tetracycline. |
| Control | Active comparator | Drug: 10RCA10-day standard triple therapy. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient proved with infection of H. pylori in gastric mucosa
- adult with signed inform consent
Key exclusion criteria (4 listed)
- woman in breast feeding or pregnancy.
- allergy to drugs used in study.
- three months without use of any antibiotic agents.
- patients under 20 years old.
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 |
|---|---|---|
| 5RA-5RCMAlso: Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Flagyl x last 5 daysrabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days. | Drug | Seq-Metronidazole |
| 5RA-5RCTAlso: Pariet x 10 days, Hiconcil x 1st 5 days then, Klaricid x last 5 days +, Acromycin x last 5 days.rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days. | Drug | Seq-Tetracycline |
| 10RCAAlso: Pariet x 10 days, Klaricid x 10 days, Hiconcil x 10 days.rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days. | Drug | Control |
Primary outcome
Eradication rate
Time frame: 4 weeks after complete use of drug for treatment
A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for 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 10 Apr 2012.
- Background: PubMed 16918889Graham DY, Abudayyeh S, El-Zimaity HM, Hoffman J, Reddy R, Opekun AR. Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Sep 1;24(5):845-50. doi: 10.1111/j.1365-2036.2006.03072.x.
- Background: PubMed 18490667Jafri NS, Hornung CA, Howden CW. Meta-analysis: sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 Jun 17;148(12):923-31. doi: 10.7326/0003-4819-148-12-200806170-00226. Epub 2008 May 19.
- Background: PubMed 17438314Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63. doi: 10.7326/0003-4819-146-8-200704170-00006.
- Background: PubMed 18516011Choi WH, Park DI, Oh SJ, Baek YH, Hong CH, Hong EJ, Song MJ, Park SK, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. [Effectiveness of 10 day-sequential therapy for Helicobacter pylori eradication in Korea]. Korean J Gastroenterol. 2008 May;51(5):280-4. Korean.
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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.
Ming-Cheh CHEN, MD principal investigator
Buddhist Tzu Chi General 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 5RA-5RCM, 5RA-5RCT and 10RCA in people with Helicobacter Pylori Infection, run by Buddhist Tzu Chi General 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 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 10 Apr 2012. 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?
Eradication rate (time frame: 4 weeks after complete use of drug for treatment). 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 NCT01573975, which also lists 4 linked publications.
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 10 Apr 2012.