Helicobacter Pylori InfectionPhase 4NCT02732249
Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment
A Phase 4 study testing Esomeprazole, Bismuth Potassium Citrate and Clarithromycin in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Bismuth Potassium Citrate and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2016to 30 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- confirmed H. pylori infection
Who cannot join
- Previous H. pylori eradication therapy
- Less than 18 years old
- With history of H. pylori infection treatment
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Bismuth Potassium Citrate, Clarithromycin, Metronidazole
- Keywords
- Helicobacter pylori, Clarithromycin, Amoxicillin, Metronidazole, Eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Given 30 min before morning and evening meals
Bismuth Potassium CitrateDrug
Given 30 min before morning and evening meals
ClarithromycinDrug
Given 30 min after morning and evening meals
MetronidazoleDrug
Given 30 min after meals or at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Triple regimen group | Active comparator | Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Receives: Drug: Esomeprazole; Drug: Clarithromycin; Drug: Metronidazole |
| Low metronidazole group | Experimental | Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Clarithromycin; Drug: Metronidazole |
| High metronidazole group | Experimental | Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Clarithromycin; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Measured: Six weeks after completion of therapy
Secondary outcomes (2)
Rate of adverse effects
Measured: within 7 days after completion of therapy
Compliance rate
Measured: within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start1 Apr 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hong lu, MD, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732249
- Sponsor's protocol ID
- rjkls2016068
- Status last verified
- Jun 2018
- First submitted
- 4 Apr 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Clarithromycin/Bismuth Containing Quadruple Therapy for Helicobacter Pylori First-line Treatment
- ClinicalTrials.gov ID
- NCT02732249
- Acronym / sponsor ID
- rjkls2016068
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Clarithromycin, Amoxicillin, Metronidazole, Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 8 Apr 2016 (estimated)
- 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.
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple regimen group | Active comparator | Drug: Esomeprazole, Drug: Clarithromycin, Drug: MetronidazoleEsomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days |
| Low metronidazole group | Experimental | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Clarithromycin, Drug: MetronidazoleEsomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days |
| High metronidazole group | Experimental | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Clarithromycin, Drug: MetronidazoleEsomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- confirmed H. pylori infection
Key exclusion criteria (8 listed)
- Previous H. pylori eradication therapy
- Less than 18 years old
- With history of H. pylori infection treatment
- With previous gastric surgery
- Major systemic diseases
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 |
|---|---|---|
| EsomeprazoleGiven 30 min before morning and evening meals | Drug | High metronidazole group, Low metronidazole group, Triple regimen group |
| Bismuth Potassium CitrateGiven 30 min before morning and evening meals | Drug | High metronidazole group, Low metronidazole group |
| ClarithromycinGiven 30 min after morning and evening meals | Drug | High metronidazole group, Low metronidazole group, Triple regimen group |
| MetronidazoleGiven 30 min after meals or at bedtime | Drug | High metronidazole group, Low metronidazole group, Triple regimen group |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
2 secondary outcomes
Rate of adverse effects
Time frame: within 7 days after completion of therapy
Compliance rate
Time frame: within 7 days after completion of therapy
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 26 Jun 2018.
- 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.
Hong lu, MD principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
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 Esomeprazole, Bismuth Potassium Citrate and Clarithromycin in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 8 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 26 Jun 2018. 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 China. 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?
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?
Helicobacter pylori eradication rate (time frame: Six weeks after completion of 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 26 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.