Helicobacter Pylori InfectionPhase 4NCT04531059
Rescue Therapy for Helicobacter Pylori Eradication Treatment
A Phase 4 study testing Esomeprazole, Bismuth Potassium Citrate and Tetracycline,Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial summary
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. 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, Bismuth Potassium Citrate and Tetracycline,Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 3 sitesChina
- Study dates
- 15 Oct 2020to 31 Dec 2022
- 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
- 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
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
- contraindications to the study drugs
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Bismuth Potassium Citrate, Tetracycline,Metronidazole, Minocycline,Metronidazole
- Keywords
- Helicobacter pylori, rescue therapy, minocycline, tetracycline
- Medical subject headings
- cyclopia sequence
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
Tetracycline,MetronidazoleDrug
Antibiotics for H. pylori eradication
Minocycline,MetronidazoleDrug
Antibiotics for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Tetracycline,Metronidazole |
| Minocycline Bismuth Quadruple Therapy | Experimental | Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Minocycline,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 posted28 Aug 2020
- Study start15 Oct 2020
- Primary completion20 Dec 2022
- Study completion31 Dec 2022
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
- None (open label)
- Enrolment
- 368 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, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531059
- Sponsor's protocol ID
- rjkls2019013
- Status last verified
- Jan 2023
- First submitted
- 25 Aug 2020
- Last updated
- 30 Dec 2024
- 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 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Therapy for Helicobacter Pylori Eradication: a Randomized Non-Inferiority Trial of Minocycline or Tetracycline in Bismuth Quadruple Therapy
- ClinicalTrials.gov ID
- NCT04531059
- Acronym / sponsor ID
- rjkls2019013
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, rescue therapy, minocycline, tetracycline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Aug 2020 (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.
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Tetracycline,MetronidazoleEsomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid |
| Minocycline Bismuth Quadruple Therapy | Experimental | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Minocycline,MetronidazoleEsomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 (7 listed)
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- severe systemic diseases or malignancy
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 | Minocycline Bismuth Quadruple Therapy, Tetracycline Bismuth Quadruple Therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Minocycline Bismuth Quadruple Therapy, Tetracycline Bismuth Quadruple Therapy |
| Tetracycline,MetronidazoleAntibiotics for H. pylori eradication | Drug | Tetracycline Bismuth Quadruple Therapy |
| Minocycline,MetronidazoleAntibiotics for H. pylori eradication | Drug | Minocycline Bismuth Quadruple 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 30 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 Tetracycline,Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 3 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 2 inclusion and 7 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 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 30 Dec 2024.