Helicobacter Pylori InfectionPhase 4NCT02935010
Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment
A Phase 4 study testing Esomeprazole, Bismuth Potassium Citrate and Amoxicillin in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 5 sites in China.
Trial summary
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. 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 Amoxicillin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 5 sitesChina
- Study dates
- 5 Feb 2017to 31 Mar 2018
- 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
5 sites in 1 country.
5 sites in 1 country
China5 sites
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200001
Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200001
Shanghai Tenth People's Hospital, Tongji University
Shanghai, Shanghai Municipality, 200001
Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, 200001
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Bismuth Potassium Citrate, Amoxicillin, Clarithromycin, Metronidazole
- Keywords
- Helicobacter pylori, Bismuth quadruple therapy, Tailored therapy, Empiric therapy, clarithromycin susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
proton pump inhibitor
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
AmoxicillinDrug
antibiotic for H. pylori eradication
ClarithromycinDrug
antibiotic for H. pylori eradication
MetronidazoleDrug
antibiotic for H. pylori eradication
LevofloxacinDrug
antibiotic for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Tailored therapy | Experimental | After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Clarithromycin; Drug: Metronidazole; Drug: Levofloxacin |
| Empiric therapy | Active comparator | give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Measured: Six weeks after completion of therapy
Secondary outcomes (2)
Rate of adverse effects
During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event.
Measured: within 7 days after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication.
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 posted17 Oct 2016 (estimated)
- Study start5 Feb 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
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
- 382 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, M.D., Study chair, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.Yunwei Sun, M.D., Principal investigator, Ruijin HospitalHong Gao, M.D., Principal investigator, Fudan UniversityYan Zhao, M.D., Principal investigator, Shanghai Tenth People's Hospital, Tongji UniversityGang Xu, M.D., Principal investigator, Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935010
- Sponsor's protocol ID
- rjkls2016110
- Status last verified
- Aug 2018
- First submitted
- 11 Oct 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02935010
- Acronym / sponsor ID
- rjkls2016110
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Bismuth quadruple therapy, Tailored therapy, Empiric therapy, clarithromycin susceptibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 5 Feb 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 17 Oct 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.
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored therapy | Experimental | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Amoxicillin, Drug: Clarithromycin, Drug: Metronidazole, Drug: LevofloxacinAfter antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. |
| Empiric therapy | Active comparator | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Amoxicillin, Drug: Metronidazolegive esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid 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 |
|---|---|---|
| Esomeprazoleproton pump inhibitor | Drug | Empiric therapy, Tailored therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Empiric therapy, Tailored therapy |
| Amoxicillinantibiotic for H. pylori eradication | Drug | Empiric therapy, Tailored therapy |
| Clarithromycinantibiotic for H. pylori eradication | Drug | Tailored therapy |
| Metronidazoleantibiotic for H. pylori eradication | Drug | Empiric therapy, Tailored therapy |
| Levofloxacinantibiotic for H. pylori eradication | Drug | Tailored therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
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 15 Aug 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, M.D. study chair
Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
Yunwei Sun, M.D. principal investigator
Ruijin Hospital
Hong Gao, M.D. principal investigator
Fudan University
5 sites 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 Amoxicillin in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 5 sites 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 15 Aug 2018.