Functional DyspepsiaPhase 4NCT01668927
Empirical Rescue Therapies of Helicobacter Pylori Infection
A Phase 4 study testing Proton Pump Inhibitor, Bismuth and Metronidazole in people with Functional Dyspepsia and Scarred Peptic Ulcer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dyspepsia, Scarred Peptic Ulcer
- What is being tested?
- Proton Pump Inhibitor, Bismuth and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.
Who cannot join
- less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Treatment
The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.
- Conditions
- Functional Dyspepsia, Scarred Peptic Ulcer
- Being tested
- Proton Pump Inhibitor, Bismuth, Metronidazole, Tetracycline, Furazolidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump InhibitorDrug
Also called Lansoprazole
BismuthDrug
Also called Bismuth potassium citrate
MetronidazoleDrug
TetracyclineDrug
FurazolidoneDrug
AmoxicillinDrug
| Study group | Role | What they receive |
|---|---|---|
| tetracycline/furazolidone | Experimental | one of the four empirical rescue therapies Receives: Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Tetracycline; Drug: Furazolidone |
| amoxicillin/tetracycline | Experimental | one of the four empirical rescue therapies Receives: Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Tetracycline; Drug: Amoxicillin |
| amoxicillin/furazolidone | Experimental | one of the four empirical rescue therapies Receives: Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Furazolidone; Drug: Amoxicillin |
| tetracycline /metronidazole | Active comparator | Classical rescue therapy Receives: Drug: Proton Pump Inhibitor; Drug: Bismuth; Drug: Metronidazole; Drug: Tetracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate of H. 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 posted20 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionOct 2012
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 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
- 424 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668927
- Sponsor's protocol ID
- rjkls_2012009
- Status last verified
- Jun 2013
- First submitted
- 16 Aug 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, Xiao S, Lu H. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013 Jul;11(7):802-7.e1. doi: 10.1016/j.cgh.2013.01.008. Epub 2013 Jan 29.
PubMed 23376004
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Treatment
- ClinicalTrials.gov ID
- NCT01668927
- Acronym / sponsor ID
- rjkls_2012009
- Conditions
- Functional Dyspepsia, Scarred Peptic Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 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.
The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone, amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these three antimicrobials was rare. It is necessary to assess the efficacy and safety of these four bismuth-containing quadruple regimens with above antibiotics as empirical rescue therapies for H. pylori eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tetracycline/furazolidone | Experimental | Drug: Proton Pump Inhibitor, Drug: Bismuth, Drug: Tetracycline, Drug: Furazolidoneone of the four empirical rescue therapies |
| amoxicillin/tetracycline | Experimental | Drug: Proton Pump Inhibitor, Drug: Bismuth, Drug: Tetracycline, Drug: Amoxicillinone of the four empirical rescue therapies |
| amoxicillin/furazolidone | Experimental | Drug: Proton Pump Inhibitor, Drug: Bismuth, Drug: Furazolidone, Drug: Amoxicillinone of the four empirical rescue therapies |
| tetracycline /metronidazole | Active comparator | Drug: Proton Pump Inhibitor, Drug: Bismuth, Drug: Metronidazole, Drug: TetracyclineClassical rescue therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who had previously failed one or more eradication regimens containing clarithromycin, metronidazole and/or amoxicillin.
Key exclusion criteria (1 listed)
- less than 18 years old, never receiving eradication treatment before, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks
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 InhibitorAlso: Lansoprazole | Drug | amoxicillin/furazolidone, amoxicillin/tetracycline, tetracycline /metronidazole, tetracycline/furazolidone |
| BismuthAlso: Bismuth potassium citrate | Drug | amoxicillin/furazolidone, amoxicillin/tetracycline, tetracycline /metronidazole, tetracycline/furazolidone |
| Metronidazole | Drug | tetracycline /metronidazole |
| Tetracycline | Drug | amoxicillin/tetracycline, tetracycline /metronidazole, tetracycline/furazolidone |
| Furazolidone | Drug | amoxicillin/furazolidone, tetracycline/furazolidone |
| Amoxicillin | Drug | amoxicillin/furazolidone, amoxicillin/tetracycline |
Primary outcome
eradication rate of H. 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 4 Jun 2013.
- Derived from this study: PubMed 23376004Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, Xiao S, Lu H. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013 Jul;11(7):802-7.e1. doi: 10.1016/j.cgh.2013.01.008. Epub 2013 Jan 29.
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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.
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 and Metronidazole in people with Functional Dyspepsia and Scarred 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 4 Jun 2013. 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 H. 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?
On the ClinicalTrials.gov record for NCT01668927, 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 4 Jun 2013.