Helicobacter Pylori InfectionPhase 4NCT03405584
High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment
A Phase 4 study testing Esomeprazole, Amoxicillin and Bismuth Potassium Citrate in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Amoxicillin and Bismuth Potassium Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2018to 2 Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with non-ulcer functional dyspepsia or 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
- Less than 18 years old
- 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: Efficacy of High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment：a Randomized Clinical Trial
Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Amoxicillin, Bismuth Potassium Citrate
- Keywords
- Helicobacter pylori, Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Proton pump inhibitor
AmoxicillinDrug
Antibiotic for H. pylori eradication
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
| Study group | Role | What they receive |
|---|---|---|
| Bismuth Plus Dual Therapy | Experimental | Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days. Receives: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate |
| Dual Therapy | Active comparator | Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days. Receives: Drug: Esomeprazole; Drug: Amoxicillin |
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
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).
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 posted23 Jan 2018
- Study start3 Jan 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 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
- 160 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, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405584
- Sponsor's protocol ID
- rjkls2017196
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2018
- Last updated
- 5 Nov 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 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Dose of Dual Therapy Plus Bismuth for Helicobacter Pylori Treatment：a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03405584
- Acronym / sponsor ID
- rjkls2017196
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 23 Jan 2018 (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.
Dual therapy for Helicobacter Pylori including a proton pump inhibitor (PPI) and amoxicillin. Amoxicillin has low resistance rate as well as low percentage of side effects. No trial has examined the the efficacy of high dose of dual therapy plus bismuth for H. pylori treatment.This study is designed to evaluate the efficacy and safety of the addition of bismuth to high dose of dual therapy for H. pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bismuth Plus Dual Therapy | Experimental | Drug: Esomeprazole, Drug: Amoxicillin, Drug: Bismuth Potassium CitrateEsomeprazole 40mg bid, Amoxicillin 1.0g tid and Bismuth Potassium Citrate 600mg bid for 14 days. |
| Dual Therapy | Active comparator | Drug: Esomeprazole, Drug: AmoxicillinEsomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with non-ulcer functional dyspepsia or 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 (5 listed)
- Less than 18 years old
- 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
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 | Bismuth Plus Dual Therapy, Dual Therapy |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | Bismuth Plus Dual Therapy, Dual Therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Bismuth Plus Dual 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 5 Nov 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 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, Amoxicillin and Bismuth Potassium Citrate 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 5 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 5 Nov 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 5 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.