Helicobacter Pylori InfectionNCT02646332
Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy
A study testing (dexlan+amox+clar+metr)+(dexlan+amox) and dexlan+clarith+amox+metro in people with Helicobacter Pylori Infection, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered. 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?
- (dexlan+amox+clar+metr)+(dexlan+amox) and dexlan+clarith+amox+metro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2015to 31 Aug 2020
- Phase
- Interventional
- 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 or bismuth 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: Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication
Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
Read the detailed description
A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- (dexlan+amox+clar+metr)+(dexlan+amox), dexlan+clarith+amox+metro
- Keywords
- Helicobacter pylori, Eradication rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(dexlan+amox+clar+metr)+(dexlan+amox)Drug
Also called dexlansoprazole MR 60 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 250 mg
a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily
dexlan+clarith+amox+metroDrug
Also called dexlansoprazole MR 60 mg, clarithromycin 500 mg, amoxicillin 1 g, metronidazole 250 mg
dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| (dexlan+amox+clar+metr)+(dexlan+amox) | Experimental | a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily Receives: Drug: (dexlan+amox+clar+metr)+(dexlan+amox) |
| dexlan+clarith+amox+metro | Active comparator | dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days Receives: Drug: dexlan+clarith+amox+metro |
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
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.
Measured: sixth 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 posted5 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 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, Bachelor, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646332
- Sponsor's protocol ID
- VGHKS15-CT7-15
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2016
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Impact on Gastrointestinal Microbiota of Reverse Hybrid Therapy and Concomitant Therapy in Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT02646332
- Acronym / sponsor ID
- VGHKS15-CT7-15
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Eradication rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Dec 2015
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
Detailed description
A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (dexlan+amox+clar+metr)+(dexlan+amox) | Experimental | Drug: (dexlan+amox+clar+metr)+(dexlan+amox)a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily |
| dexlan+clarith+amox+metro | Active comparator | Drug: dexlan+clarith+amox+metrodexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 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 or bismuth 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 |
|---|---|---|
| (dexlan+amox+clar+metr)+(dexlan+amox)Also: dexlansoprazole MR 60 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 250 mga 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily | Drug | (dexlan+amox+clar+metr)+(dexlan+amox) |
| dexlan+clarith+amox+metroAlso: dexlansoprazole MR 60 mg, clarithromycin 500 mg, amoxicillin 1 g, metronidazole 250 mgdexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days | Drug | dexlan+clarith+amox+metro |
Primary outcome
Number of Participants in Which H. Pylori Was Eradicated
Time frame: sixth week after the end of anti- H. pylori therapy
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture 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 24 Nov 2020.
- 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.
Ping-I Hsu, Bachelor 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 study testing (dexlan+amox+clar+metr)+(dexlan+amox) and dexlan+clarith+amox+metro 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 24 Nov 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2020). 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 in Which H. Pylori Was Eradicated (time frame: sixth 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?
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 24 Nov 2020.