Helicobacter Pylori InfectionPhase 4NCT03108287
Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori
A Phase 4 study testing RAK therapy and RBAK therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- RAK therapy and RBAK therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 28 Feb 2015
- 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
- male or non-pregnant female aged more than 20 y/r
- H.pylori-infected
- mental and legal ability to give a written informed consent
Who cannot join
- allergy to any drug in the study
- prior gastric surgery, severe concomitant diseases (e.g., decompensate liver cirrhosis, uremia, gastric cancer)
- previous H. pylori eradication therapy
- pregnancy or lactation.
About this study
This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.
Read the detailed description
Once confirmed with H. pylori infection and having signed the informed consent, participants were randomly assigned to either the standard triple-therapy group (RAK: rabeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days) or the bismuth plus standard triple-therapy group (RBAK: rabeprazole 20 mg, bismuth subcitrate 360 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days). A computer-generated random number was chosen for randomization. The patients and physicians were not blinded to the therapy assigned.
After completion of H. pylori eradication therapy, participants were asked to come back for collection of the information on any adverse event of drug compliance. In order to avoid false negative results, they were also asked to have a 4-week proton pump inhibitor, antibiotic and bismuth washout period before further examination of H. pylori status. The second endoscopy with rapid urea test, histology and culture or 13 C-urea breath test (UBT) for those who refused endoscopic exams was carried out at the end of the washout period. Those who did not return to confirm their H. pylori status were deemed as treatment failure in intention-to-treat (ITT) analysis.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- RAK therapy, RBAK therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAK therapyDrug
Also called rabeprazole, amoxicillin, clarithromycin
rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily
RBAK therapyDrug
Also called rabeprazole, amoxicillin, clarithromycin, bismuth subcitrate
rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily
| Study group | Role | What they receive |
|---|---|---|
| RAK therapy | Active comparator | rabeprazole+amoxicillin+clarithromycin Receives: Drug: RAK therapy |
| RBAK therapy | Active comparator | rabeprazole+amoxicillin+clarithromycin+bismuth subcitrate Receives: Drug: RBAK therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of H.pylori eradication
Helicobacter pylori eradication was assessed by ¹³C-urea breath test. [cutoff value(<4‰)]
Measured: 4 weeks after finishing study drugs
Secondary outcomes (2)
rate of drug compliance
good drug compliance measure by no of subjects taking >80% medicines
Measured: 4 weeks after finishing study drugs
rate of side effects
Score side effects were mild, moderate or severe according to their influence on daily activities
Measured: 4 weeks after finishing study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Apr 2013
- Primary completion31 Jan 2015
- Study completion28 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Chen Wu, MD, PhD, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108287
- Sponsor's protocol ID
- KMUH-IRB-20120028
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT03108287
- Acronym / sponsor ID
- KMUH-IRB-20120028
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Jan 2015 (actual)
- Study completion
- 28 Feb 2015 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.
Detailed description
Once confirmed with H. pylori infection and having signed the informed consent, participants were randomly assigned to either the standard triple-therapy group (RAK: rabeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days) or the bismuth plus standard triple-therapy group (RBAK: rabeprazole 20 mg, bismuth subcitrate 360 mg, amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days). A computer-generated random number was chosen for randomization. The patients and physicians were not blinded to the therapy assigned.
After completion of H. pylori eradication therapy, participants were asked to come back for collection of the information on any adverse event of drug compliance. In order to avoid false negative results, they were also asked to have a 4-week proton pump inhibitor, antibiotic and bismuth washout period before further examination of H. pylori status. The second endoscopy with rapid urea test, histology and culture or 13 C-urea breath test (UBT) for those who refused endoscopic exams was carried out at the end of the washout period. Those who did not return to confirm their H. pylori status were deemed as treatment failure in intention-to-treat (ITT) analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAK therapy | Active comparator | Drug: RAK therapyrabeprazole+amoxicillin+clarithromycin |
| RBAK therapy | Active comparator | Drug: RBAK therapyrabeprazole+amoxicillin+clarithromycin+bismuth subcitrate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or non-pregnant female aged more than 20 y/r
- H.pylori-infected
- mental and legal ability to give a written informed consent
Key exclusion criteria (4 listed)
- allergy to any drug in the study
- prior gastric surgery, severe concomitant diseases (e.g., decompensate liver cirrhosis, uremia, gastric cancer)
- previous H. pylori eradication therapy
- pregnancy or lactation.
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 |
|---|---|---|
| RAK therapyAlso: rabeprazole, amoxicillin, clarithromycinrabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily | Drug | RAK therapy |
| RBAK therapyAlso: rabeprazole, amoxicillin, clarithromycin, bismuth subcitraterabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily | Drug | RBAK therapy |
Primary outcome
The rate of H.pylori eradication
Time frame: 4 weeks after finishing study drugs
Helicobacter pylori eradication was assessed by ¹³C-urea breath test. [cutoff value(<4‰)]
2 secondary outcomes
rate of drug compliance
Time frame: 4 weeks after finishing study drugs
rate of side effects
Time frame: 4 weeks after finishing study drugs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Individual participant dataSharing planned: No
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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.
I-Chen Wu, MD, PhD study chair
Kaohsiung Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RAK therapy and RBAK therapy in people with Helicobacter Pylori Infection, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 3 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: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of H.pylori eradication (time frame: 4 weeks after finishing study drugs). 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 Apr 2017.