Helicobacter Pylori InfectionPhase 4NCT04024527
High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
A Phase 4 study testing Esomeprazole, Amoxicillin and Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole 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 Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2019to 24 May 2021
- 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 and with previous treatment failure
Who cannot join
- Less than 18 years old or older than 80 years
- 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 Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial
Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Amoxicillin, Metronidazole
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
MetronidazoleDrug
Antibiotic for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy | Active comparator | Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days Receives: Drug: Esomeprazole; Drug: Amoxicillin |
| Metronidazole plus dual therapy | Experimental | Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Receives: Drug: Esomeprazole; 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
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 posted18 Jul 2019
- Study start25 Jul 2019
- Primary completion12 Apr 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 306 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.,Ph.D., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024527
- Sponsor's protocol ID
- rjyy20190715
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding ZH, Huang Y, Chen JN, Luo LS, Zhang W, Liang X, Lu H. A randomized superiority clinical trial: metronidazole improved the efficacy of high-dose dual therapy in Helicobacter pylori rescue treatment. J Antimicrob Chemother. 2023 Mar 2;78(3):828-831. doi: 10.1093/jac/dkad020.
PubMed 36719104
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori Rescue Treatment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04024527
- Acronym / sponsor ID
- rjyy20190715
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 18 Jul 2019 (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 containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual therapy | Active comparator | Drug: Esomeprazole, Drug: AmoxicillinEsomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days |
| Metronidazole plus dual therapy | Experimental | Drug: Esomeprazole, Drug: Amoxicillin, Drug: MetronidazoleEsomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g 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 and with previous treatment failure
Key exclusion criteria (6 listed)
- Less than 18 years old or older than 80 years
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
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 | Dual therapy, Metronidazole plus dual therapy |
| AmoxicillinAntibiotic for H. pylori eradication | Drug | Dual therapy, Metronidazole plus dual therapy |
| MetronidazoleAntibiotic for H. pylori eradication | Drug | Metronidazole 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 28 Sep 2021.
- Derived from this study: PubMed 36719104Ding ZH, Huang Y, Chen JN, Luo LS, Zhang W, Liang X, Lu H. A randomized superiority clinical trial: metronidazole improved the efficacy of high-dose dual therapy in Helicobacter pylori rescue treatment. J Antimicrob Chemother. 2023 Mar 2;78(3):828-831. doi: 10.1093/jac/dkad020.
- 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.,Ph.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 Metronidazole 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 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 28 Sep 2021. 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?
On the ClinicalTrials.gov record for NCT04024527, which also lists 1 linked publication.
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 28 Sep 2021.