Helicobacter Pylori InfectionPhase 4NCT01769365
Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection
A Phase 4 study testing 7-day quadruple therapy, 10-day sequential therapy and 7-day standard triple therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- 7-day quadruple therapy, 10-day sequential therapy and 7-day standard triple therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2010to Oct 2013
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Who cannot join
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or proton pump inhibitors 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
1 site in 1 country.
About this study
Official title: Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
Read the detailed description
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.
A total of 306 subjects are enrolled into this study.
- pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- 7-day quadruple therapy, 10-day sequential therapy, 7-day standard triple therapy
- Keywords
- Helicobacter pylori infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day quadruple therapyDrug
Also called Pantoprazole, amoxicillin, clarithromycin, metronidazole
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
10-day sequential therapyDrug
Also called sequential group
pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
7-day standard triple therapyDrug
Also called pantoprazole, clarithromycin, amoxicillin
pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| 7-day quadruple therapy | Experimental | 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days,
4. metronidazole 500 mg twice daily for 7 days Receives: Drug: 7-day quadruple therapy |
| 10-day sequential therapy | Experimental | 1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by
2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days. Receives: Drug: 10-day sequential therapy |
| 7-day standard triple therapy | Active comparator | 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days. Receives: Drug: 7-day standard triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Eradication of Helicobacter Pylori
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Measured: at the 6th week after the end of anti- H. pylori therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionOct 2013
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.
- Publications (1)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
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
- Investigators
- Ping-I Hsu, MD, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769365
- Sponsor's protocol ID
- VGHKS99-CT7-10
- Status last verified
- Sep 2015
- First submitted
- 14 Jan 2013
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28.
PubMed 25070099
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 7-day Triple, 10-day Sequential, and 7-day Concomitant Therapies for Helicobacter Pylori Infection in Taiwan
- ClinicalTrials.gov ID
- NCT01769365
- Acronym / sponsor ID
- VGHKS99-CT7-10
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Posted 6 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.
Detailed description
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.
A total of 306 subjects are enrolled into this study.
- pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7-day quadruple therapy | Experimental | Drug: 7-day quadruple therapy1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days, 4. metronidazole 500 mg twice daily for 7 days |
| 10-day sequential therapy | Experimental | Drug: 10-day sequential therapy1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by 2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days. |
| 7-day standard triple therapy | Active comparator | Drug: 7-day standard triple therapy1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Key exclusion criteria (6 listed)
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or proton pump inhibitors 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)
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 |
|---|---|---|
| 7-day quadruple therapyAlso: Pantoprazole, amoxicillin, clarithromycin, metronidazolepantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days | Drug | 7-day quadruple therapy |
| 10-day sequential therapyAlso: sequential grouppantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days | Drug | 10-day sequential therapy |
| 7-day standard triple therapyAlso: pantoprazole, clarithromycin, amoxicillinpantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days | Drug | 7-day standard triple therapy |
Primary outcome
Number of Participants With Complete Eradication of Helicobacter Pylori
Time frame: at the 6th week after the end of anti- H. pylori therapy
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25070099Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28.
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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.
Ping-I Hsu, MD study chair
Kaohsiung Veterans 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 7-day quadruple therapy, 10-day sequential therapy and 7-day standard triple therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans 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 1 inclusion and 6 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 17 Nov 2017. 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 6 Oct 2015). 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?
Number of Participants With Complete Eradication of Helicobacter Pylori (time frame: at the 6th week after the end of anti- H. pylori therapy). 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 NCT01769365, which also lists 1 linked publication.
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 17 Nov 2017.