Helicobacter Pylori InfectionPhase 4NCT01575899
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori
A Phase 4 study testing Levofloxacin-Amox/clav. and Clarithromycin-Amoxicillin in people with Helicobacter Pylori Infection, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan. 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?
- Levofloxacin-Amox/clav. and Clarithromycin-Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2007to Dec 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient with signed informed consent.
Who cannot join
- woman in breast feeding or pregnancy.
- allergy or severe adverse effects to drugs used in study.
- severe complications of peptic ulcer disease (like perforation or obstruction).
- patients with history of cancer or failure of major organs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.
This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.
Read the detailed description
BACKGROUND:
The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection.
AIM:
To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection.
METHODS:
We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up.
EXPECTED RESULT:
The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Levofloxacin-Amox/clav., Clarithromycin-Amoxicillin
- Keywords
- Helicobacter pylori, Levofloxacin, Amoxicillin/clavulanate, Rabeprazole, Eastern Taiwan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin-Amox/clav.Drug
Also called Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and, Rabeprazole(Pariet) for 7 days.
Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
Clarithromycin-AmoxicillinDrug
Also called Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and, Rabeprazole(Pariet) for 7 days.
Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin-Amoxicillin/clavulanate | Experimental | 7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. Receives: Drug: Levofloxacin-Amox/clav. |
| Clarithromycin-Amoxicillin | Active comparator | 7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. Receives: Drug: Clarithromycin-Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication Rate (Participants Naive to Anti-H. Pylori 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.
Measured: 4 weeks after complete use of drug for treatment
Secondary outcomes (1)
Eradication Rate of Participants Living in Rural Area.
Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.
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 posted12 Apr 2012 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Early termination due to efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 208 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
- NCT01575899
- Sponsor's protocol ID
- IRB096-28
- Status last verified
- Jul 2012
- First submitted
- 10 Apr 2012
- Last updated
- 31 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori.
- ClinicalTrials.gov ID
- NCT01575899
- Acronym / sponsor ID
- IRB096-28
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Levofloxacin, Amoxicillin/clavulanate, Rabeprazole, Eastern Taiwan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to efficacy
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 31 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective controlled randomized open-label clinical trial is designed to determine the eradication rate of 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole regimen compared with 7-day standard triple therapy for adults infected with Helicobacter pylori in Eastern Taiwan.
Detailed description
BACKGROUND:
The resistance rate of Helicobacter pylori (Hp) to amoxicillin and metronidazole therapy is significantly higher in Eastern Taiwan as compared to national and worldwide rates. The high resistance rate in this territory justified a search for a better eradication regimen for Hp infection.
AIM:
To evaluate the efficacy and tolerability of a combination therapeutic regimen of levofloxacin, amoxicillin/clavulanate and rabeprazole (LAcR) versus a conventional seven-day triple therapy with clarithromycin, amoxicillin and rabeprazole (CAR) for the eradication of Hp infection.
METHODS:
We conducted a open-labeled, prospective, randomized, controlled study in a large tertiary referral hospital in Eastern Taiwan. Hp-positive therapy-naïve patients with a positive CLO test as proven by gastroscopy were recruited for potential random assignment to two 7-day treatment groups: LAcR or CAR (control). The primary end point of this study was to evaluate the eradication rate of LAcR regimen. Hp eradication was assessed using the 13C-urea breath test or CLO test performed at least 4 weeks after end of treatment. Compliance and adverse effects with therapy were determined by phone call or outpatient clinic follow up.
EXPECTED RESULT:
The seven-day LAcR regimen evaluated in this study provided improved Hp eradication efficacy when compared with the traditional seven-day triple therapy in Eastern Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin-Amoxicillin/clavulanate | Experimental | Drug: Levofloxacin-Amox/clav.7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication. |
| Clarithromycin-Amoxicillin | Active comparator | Drug: Clarithromycin-Amoxicillin7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication. |
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
- Patient with signed informed consent.
Key exclusion criteria (4 listed)
- woman in breast feeding or pregnancy.
- allergy or severe adverse effects to drugs used in study.
- severe complications of peptic ulcer disease (like perforation or obstruction).
- patients with history of cancer or failure of major organs.
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-Amox/clav.Also: Levofloxacin(Cravit), Amoxicillin/clavulanate(Augmentin) and, Rabeprazole(Pariet) for 7 days.Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days. | Drug | Levofloxacin-Amoxicillin/clavulanate |
| Clarithromycin-AmoxicillinAlso: Clarithromycin(Klaricid), Amoxicillin(Hiconcil) and, Rabeprazole(Pariet) for 7 days.Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days. | Drug | Clarithromycin-Amoxicillin |
Primary outcome
Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
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.
1 secondary outcome
Eradication Rate of Participants Living in Rural Area.
Time frame: 4 weeks after complete use of drug for treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Levofloxacin-Amox/clav. and Clarithromycin-Amoxicillin 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: stopped early, as of the sponsor's last update on 31 Aug 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?
Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (Participants Naive to Anti-H. Pylori Treatment) (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?
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 31 Aug 2012.