Eradication Rates of the Two RegimensPhase 4THCNCT01607918
Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy
A Phase 4 study testing D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) and D1-D14: (lansoprazole + clarithromycin + amoxicillin) in people with Eradication Rates of the Two Regimens, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Eradication Rates of the Two Regimens
- What is being tested?
- D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) and D1-D14: (lansoprazole + clarithromycin + amoxicillin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Jun 2014
- 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
- Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
- Written informed consents will be obtained from all patients prior to enrollment.
Who cannot join
- Patients will be excluded from the study if any one of the following criteria is present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
- pregnant or lactating women,
- severe concurrent disease
- Patients who cannot give informed consent by himself or herself.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Jyh-Ming Liou, MD, 886-972651883, dtmed046@pchome.com.tw
Jyh-Ming Liou, MD
About this study
Official title: Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days
- Conditions
- Eradication Rates of the Two Regimens
- Being tested
- D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole), D1-D14: (lansoprazole + clarithromycin + amoxicillin)
- Keywords
- H pylori, eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)Drug
Also called Takepron, Amoxicillin, Klaricid, Flagyl
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
D1-D14: (lansoprazole + clarithromycin + amoxicillin)Drug
Also called Takepron, Klaricid, Amoxicillin
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
| Study group | Role | What they receive |
|---|---|---|
| Sequential therapy 10 days | Experimental | Sequential therapy Receives: Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) |
| Triple therapy 14 days | Active comparator | Triple therapy Receives: Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
C13-UBT will be used to assess the existence of H. pylori
Measured: 6 weeks
Secondary outcomes (1)
Incidence of adverse effects
to assess the adverse effects
Measured: during eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eradication Rates of the Two RegimensStudies 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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Jyh-Ming Liou, MD, Principal investigator, National Taiwan University HospitalMing-Shiang Wu, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607918
- Sponsor's protocol ID
- 201110019MD
- Acronym
- THC
- Status last verified
- Oct 2013
- First submitted
- 16 Feb 2012
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Romano M, Cuomo A, Gravina AG, Miranda A, Iovene MR, Tiso A, Sica M, Rocco A, Salerno R, Marmo R, Federico A, Nardone G. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010 Nov;59(11):1465-70. doi: 10.1136/gut.2010.215350.
PubMed 20947881Liou JM, Chen CC, Chang CY, Chen MJ, Chen CC, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Liou TC, Chang WH, Hsu YC, Tseng CH, Chang CC, Bair MJ, Liu TY, Hsieh CF, Tsao FY, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial. Gut. 2016 Nov;65(11):1784-1792. doi: 10.1136/gutjnl-2015-310142. Epub 2015 Sep 3.
PubMed 26338825
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT01607918
- Acronym / sponsor ID
- THC / 201110019MD
- Conditions
- Eradication Rates of the Two Regimens
- Keywords
- H pylori, eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 30 May 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 investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequential therapy 10 days | Experimental | Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)Sequential therapy |
| Triple therapy 14 days | Active comparator | Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)Triple therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
- Written informed consents will be obtained from all patients prior to enrollment.
Key exclusion criteria (8 listed)
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
- pregnant or lactating women,
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 |
|---|---|---|
| D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)Also: Takepron, Amoxicillin, Klaricid, FlagylD1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid | Drug | Sequential therapy 10 days |
| D1-D14: (lansoprazole + clarithromycin + amoxicillin)Also: Takepron, Klaricid, AmoxicillinD1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid | Drug | Triple therapy 14 days |
Primary outcome
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
Time frame: 6 weeks
C13-UBT will be used to assess the existence of H. pylori
1 secondary outcome
Incidence of adverse effects
Time frame: during eradication therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Results publication: PubMed 20947881Romano M, Cuomo A, Gravina AG, Miranda A, Iovene MR, Tiso A, Sica M, Rocco A, Salerno R, Marmo R, Federico A, Nardone G. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010 Nov;59(11):1465-70. doi: 10.1136/gut.2010.215350.
- Derived from this study: PubMed 26338825Liou JM, Chen CC, Chang CY, Chen MJ, Chen CC, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Liou TC, Chang WH, Hsu YC, Tseng CH, Chang CC, Bair MJ, Liu TY, Hsieh CF, Tsao FY, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Sequential therapy for 10 days versus triple therapy for 14 days in the eradication of Helicobacter pylori in the community and hospital populations: a randomised trial. Gut. 2016 Nov;65(11):1784-1792. doi: 10.1136/gutjnl-2015-310142. Epub 2015 Sep 3.
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-Ming Liou, MD principal investigator
National Taiwan University Hospital
Ming-Shiang Wu, MD, PhD 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 D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) and D1-D14: (lansoprazole + clarithromycin + amoxicillin) in people with Eradication Rates of the Two Regimens, 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 2 inclusion and 8 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 29 Oct 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-Ming Liou, MD (886-972651883, dtmed046@pchome.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis (time frame: 6 weeks). 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 NCT01607918, which also lists 2 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 29 Oct 2013.