Functional DyspepsiaPhase 4NCT01667718
Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment
A Phase 4 study testing Bismuth, Lansoprazole and Levofloxacin in people with Functional Dyspepsia and Peptic Ulcer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia, Peptic Ulcer
- What is being tested?
- Bismuth, Lansoprazole and Levofloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Oct 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer
Who cannot join
- patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao-Tong University School of Medicine Renji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.
Read the detailed description
The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.
- Conditions
- Functional Dyspepsia, Peptic Ulcer
- Being tested
- Bismuth, Lansoprazole, Levofloxacin, Amoxicillin
- Keywords
- eradication, helicobacter pylori, bismuth
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BismuthDrug
Also called Bismuth potassium citrate
Bismuth 220mg b.i.d for 2 weeks
LansoprazoleDrug
Also called Proton Pump Inhibitor
Lansoprazole 30 mg b.i.d.for 2 weeks
LevofloxacinDrug
Levofloxacin 0.5 q.d. for 2 weeks
AmoxicillinDrug
Amoxicillin 1 g b.i.d. for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin-triple therapy | Active comparator | Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin Receives: Drug: Lansoprazole; Drug: Levofloxacin; Drug: Amoxicillin |
| Levofloxacin-quadruple therapy | Experimental | Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin Receives: Drug: Bismuth; Drug: Lansoprazole; Drug: Levofloxacin; Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate of Helicobacter pylori
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 posted17 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hong Lu, Principal investigator, Shanghai Jiao-Tong University School of Medicine Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667718
- Sponsor's protocol ID
- rjkls2012011
- Status last verified
- Dec 2012
- First submitted
- 5 Jun 2012
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levofloxacin-containing Therapy for Helicobacter Pylori Treatment
- ClinicalTrials.gov ID
- NCT01667718
- Acronym / sponsor ID
- rjkls2012011
- Conditions
- Functional Dyspepsia, Peptic Ulcer
- Keywords
- eradication, helicobacter pylori, bismuth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 Aug 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 examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and without Bismuth for H.pylori treatment.
Detailed description
The success rate of the standard triple therapy for H. pylori infection is decreasing recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin-triple therapy | Active comparator | Drug: Lansoprazole, Drug: Levofloxacin, Drug: AmoxicillinLansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin |
| Levofloxacin-quadruple therapy | Experimental | Drug: Bismuth, Drug: Lansoprazole, Drug: Levofloxacin, Drug: AmoxicillinLansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcer
Key exclusion criteria (1 listed)
- patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the medications
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 |
|---|---|---|
| BismuthAlso: Bismuth potassium citrateBismuth 220mg b.i.d for 2 weeks | Drug | Levofloxacin-quadruple therapy |
| LansoprazoleAlso: Proton Pump InhibitorLansoprazole 30 mg b.i.d.for 2 weeks | Drug | Levofloxacin-quadruple therapy, Levofloxacin-triple therapy |
| LevofloxacinLevofloxacin 0.5 q.d. for 2 weeks | Drug | Levofloxacin-quadruple therapy, Levofloxacin-triple therapy |
| AmoxicillinAmoxicillin 1 g b.i.d. for 2 weeks | Drug | Levofloxacin-quadruple therapy, Levofloxacin-triple therapy |
Primary outcome
eradication rate of Helicobacter pylori
Time frame: 2 months
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 13 Dec 2012.
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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 principal investigator
Shanghai Jiao-Tong University School of Medicine Renji Hospital
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 Bismuth, Lansoprazole and Levofloxacin in people with Functional Dyspepsia and Peptic Ulcer, 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 1 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 13 Dec 2012. 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 of Helicobacter pylori (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 13 Dec 2012.