Cure Rate of Helicobacter Pylori InfectionPhase 4NCT01742429
Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
A Phase 4 study testing Proton pump inhibitor, Bismuth subsalicylate and Metronidazole in people with Cure Rate of Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Cure Rate of Helicobacter Pylori Infection
- What is being tested?
- Proton pump inhibitor, Bismuth subsalicylate and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Apr 2013
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.
Who cannot join
- patients less than 18 years old,
- previous gastric surgery,
- pregnancy,
- lactation,
- major systemic diseases,
- administration of antibiotics,
Show all 9Show fewer
- bismuth,
- antisecretory drugs in the preceding 8 weeks, or
- allergy to any one of the medication used in the quadruple regimens.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
- Being tested
- Proton pump inhibitor, Bismuth subsalicylate, Metronidazole, Tetracycline, Amoxicillin
- Keywords
- Helicobacter pylori, second line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton pump inhibitorDrug
Bismuth subsalicylateDrug
MetronidazoleDrug
antibiotic
TetracyclineDrug
antibiotic
AmoxicillinDrug
antibiotic
LevofloxacinDrug
antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin-bismuth therapy | Experimental | 14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin Receives: Drug: Proton pump inhibitor; Drug: Bismuth subsalicylate; Drug: Amoxicillin; Drug: Levofloxacin |
| classical quadruple therapy | Active comparator | 14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline Receives: Drug: Proton pump inhibitor; Drug: Bismuth subsalicylate; Drug: Metronidazole; Drug: Tetracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate
urease breath test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cure Rate of 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
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742429
- Sponsor's protocol ID
- rjkls2012008
- Status last verified
- Jun 2013
- First submitted
- 2 Dec 2012
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT01742429
- Acronym / sponsor ID
- rjkls2012008
- Keywords
- Helicobacter pylori, second line treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 5 Dec 2012 (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.
To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin-bismuth therapy | Experimental | Drug: Proton pump inhibitor, Drug: Bismuth subsalicylate, Drug: Amoxicillin, Drug: Levofloxacin14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin |
| classical quadruple therapy | Active comparator | Drug: Proton pump inhibitor, Drug: Bismuth subsalicylate, Drug: Metronidazole, Drug: Tetracycline14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.
Key exclusion criteria (9 listed)
- patients less than 18 years old,
- previous gastric surgery,
- pregnancy,
- lactation,
- 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 |
|---|---|---|
| Proton pump inhibitor | Drug | Levofloxacin-bismuth therapy, classical quadruple therapy |
| Bismuth subsalicylate | Drug | Levofloxacin-bismuth therapy, classical quadruple therapy |
| Metronidazoleantibiotic | Drug | classical quadruple therapy |
| Tetracyclineantibiotic | Drug | classical quadruple therapy |
| Amoxicillinantibiotic | Drug | Levofloxacin-bismuth therapy |
| Levofloxacinantibiotic | Drug | Levofloxacin-bismuth therapy |
Primary outcome
eradication rate
Time frame: 2 months
urease breath test
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 29 Aug 2014.
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.
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 Proton pump inhibitor, Bismuth subsalicylate and Metronidazole in people with Cure Rate of 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 1 inclusion and 9 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 29 Aug 2014. 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?
eradication rate (time frame: 2 months). 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 29 Aug 2014; AzTrials last refreshed its copy on 6 Nov 2026.