Helicobacter Pylori InfectionPhase 4NCT01085786
Sequential and Hybrid Therapies for H Pylori Infection
A Phase 4 study testing 14-day sequential treatment and 14-day hybrid treatment in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.
Trial summary
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 14-day sequential treatment and 14-day hybrid treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2008to May 2010
- Phase
- Phase 4
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Who cannot join
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Kaohsiung Veterans General Hospital
Kaohsiung City
About this study
Official title: Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
Read the detailed description
The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.
A total of 240 subjects will be asked to participate in this study.
- pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).
Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.
A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- 14-day sequential treatment, 14-day hybrid treatment
- Keywords
- Helicobacter pylori infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day sequential treatmentDrug
Also called Esomeprazole, amoxicillin, clarithromycin, metronidazole
- 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
- 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
14-day hybrid treatmentDrug
Also called esomeprazole + amoxicillin, then quadruple therapy
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 14-day sequential treatment | Active comparator | One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. Receives: Drug: 14-day sequential treatment |
| 14-day hybrid treatment | Experimental | esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days Receives: Drug: 14-day hybrid treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Which H. Pylori Was Eradicated
evaluate eradication outcome by endoscopy with urease test or urea breath test
Measured: Dec 2010
Secondary outcomes (2)
Adverse Events
by standardized questionnaire
Measured: Dec 2010
Compliance Rate
Good compliance is defined as taking equal or more than 90% of eradication medicines
Measured: Dec 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionMay 2010
- Study completionMay 2010
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, Kaohsiung Medical University
- Responsible party
- Principal investigator, Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
- Investigators
- Kwok-Hung Lai, PhD, Study chair, Kaohsiung Veterans General Hospital.David Y Graham, MD, Study director, Baylor College of MedicinePING-I Hsu, MD, PhD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085786
- Sponsor's protocol ID
- VGHKS97-CT6-08
- Status last verified
- Sep 2015
- First submitted
- 11 Mar 2010
- Last updated
- 21 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes