Eradication Rate for HelicobacterPhase 4NCT01537055
Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy
A Phase 4 study testing levofloxacin-based sequential therapy and levofloxacin-based triple therapy for 10 days in people with Eradication Rate for Helicobacter, run by National Taiwan University Hospital at 10 sites in Taiwan.
Trial summary
To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Eradication Rate for Helicobacter
- What is being tested?
- levofloxacin-based sequential therapy and levofloxacin-based triple therapy for 10 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 10 sitesTaiwan
- Study dates
- Feb 2012to Apr 2016
- 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
- H. pylori infected patients who failed from first line therapy will be eligible in this study
Who cannot join
- Patients were excluded from the study if any one of the following criteria was present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
- contraindication to treatment drugs,
- pregnant or lactating women, or
- severe concurrent disease
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Taiwan10 sites, 10 recruiting
- Recruiting
National Taiwan University Hospital, Hsinchu Branch
Hsinchu
Wen-Fong Hsu
- Recruiting
E-DA Hospital and I-Shou University
Kaohsiung City
Chi-yang Chang
- Recruiting
Kaohsiung Medical University
Kaohsiung City
Jeng-Yih Wu
- Recruiting
Health Bureau of Lienchiang County
Lienchiang
Feng-Yun Tsao
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Jyh-Ming Liou, MD, 886-972651883, dtmed046@pchome.com.tw
- Recruiting
Mackay Memorial Hospital
Taipei
Wen-Hsiung Chang
- Recruiting
Taipei Medical University Hospital
Taipei
Chun-Chao Chang
- Recruiting
Taipei Veteran General Hospital
Taipei
Jing-Chuan Luo
- Recruiting
Mackay Memorial Hospital
Taitung Branch
Ming-Jong Bair
- Recruiting
National Taiwan University Hospital , Yunlin
Yunlin
Chieh-Chang Chen
About this study
Official title: Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial
To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy
Read the detailed description
About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.
- Conditions
- Eradication Rate for Helicobacter
- Being tested
- levofloxacin-based sequential therapy, levofloxacin-based triple therapy for 10 days
- Keywords
- H pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacin-based sequential therapyDrug
Also called Takepron, Cravit, Flagyl, Amoxicillin
levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕
levofloxacin-based triple therapy for 10 daysDrug
Also called Takepron, Cravit, Amoxicillin
lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
| Study group | Role | What they receive |
|---|---|---|
| levofloxacin-based sequential therapy | Experimental | levofloxacin-based sequential therapy Receives: Drug: levofloxacin-based sequential therapy |
| levofloxacin-based triple therapy | Active comparator | levofloxacin-based triple therapy for 10 days Receives: Drug: levofloxacin-based triple therapy for 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate in the second line therapy
Assessed by UBT
Measured: 6 weeks
Secondary outcomes (1)
Incidence of adverse effect
during treatment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (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 Rate for HelicobacterStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Jyh-Ming Liou, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537055
- Sponsor's protocol ID
- 201110021MD
- Status last verified
- Jan 2015
- First submitted
- 16 Feb 2012
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
PubMed 21632579Liou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2.
PubMed 26832653
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Levofloxacin-based Sequential Therapy and Triple Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection- A Multi-center Randomized Trial
- ClinicalTrials.gov ID
- NCT01537055
- Acronym / sponsor ID
- 201110021MD
- Conditions
- Eradication Rate for Helicobacter
- Keywords
- H pylori eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- E-DA Hospital
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 22 Feb 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.
To compare the efficacy and tolerability of levofloxacin-based sequential therapy and triple therapy in the second line therapy for those who fail from one eradication therapy
Detailed description
About 600 patients who failed from first line triple therapy or sequential therapy will be eligible in this multicenter randomized comparative trial. Eligible patients will be randomized to receive either (1) levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕or (2) levofloxacin-based triple therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)〕. Eradication will be confirmed with 13C-Urea Breath Test 6 weeks after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levofloxacin-based sequential therapy | Experimental | Drug: levofloxacin-based sequential therapylevofloxacin-based sequential therapy |
| levofloxacin-based triple therapy | Active comparator | Drug: levofloxacin-based triple therapy for 10 dayslevofloxacin-based triple therapy 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)
- H. pylori infected patients who failed from first line therapy will be eligible in this study
Key exclusion criteria (8 listed)
- Patients were excluded from the study if any one of the following criteria was present:
- children and teenagers aged less than 20 years,
- history of gastrectomy,
- gastric malignancy, including adenocarcinoma and lymphoma,
- previous allergic reaction to antibiotics (amoxicillin, metronidazole, levofloxacin) and PPI (lansoprazole),
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 |
|---|---|---|
| levofloxacin-based sequential therapyAlso: Takepron, Cravit, Flagyl, Amoxicillinlevofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕 | Drug | levofloxacin-based sequential therapy |
| levofloxacin-based triple therapy for 10 daysAlso: Takepron, Cravit, Amoxicillinlansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily) | Drug | levofloxacin-based triple therapy |
Primary outcome
Eradication rate in the second line therapy
Time frame: 6 weeks
Assessed by UBT
1 secondary outcome
Incidence of adverse effect
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
- Background: PubMed 21632579Liou JM, Chen CC, Chen MJ, Chang CY, Fang YJ, Lee JY, Sheng WH, Wang HP, Wu MS, Lin JT. Empirical modified sequential therapy containing levofloxacin and high-dose esomeprazole in second-line therapy for Helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2011 Aug;66(8):1847-52. doi: 10.1093/jac/dkr217. Epub 2011 May 31.
- Derived from this study: PubMed 26832653Liou JM, Bair MJ, Chen CC, Lee YC, Chen MJ, Chen CC, Tseng CH, Fang YJ, Lee JY, Yang TH, Luo JC, Wu JY, Chang WH, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hung HW, Lin JT, Chang CY, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Levofloxacin Sequential Therapy vs Levofloxacin Triple Therapy in the Second-Line Treatment of Helicobacter pylori: A Randomized Trial. Am J Gastroenterol. 2016 Mar;111(3):381-7. doi: 10.1038/ajg.2015.439. Epub 2016 Feb 2.
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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-Ming Liou, MD principal investigator
National Taiwan University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levofloxacin-based sequential therapy and levofloxacin-based triple therapy for 10 days in people with Eradication Rate for Helicobacter, run by National Taiwan University Hospital at 10 sites 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 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 2 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 in the second line therapy (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 NCT01537055, 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 2 Feb 2015.