Treatment of Helicobacter PyloriQT-HpNCT00520949
Quadruple Therapy for Triple Therapy Resistant Helicobacter Pylori Infection
A study testing Augmentin (Amoxicillin-clavulanic), Furoxone (furazolidone) and Cebes (colloidal bismuth subcitrate) in people with Treatment of Helicobacter Pylori, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment of Helicobacter Pylori
- What is being tested?
- Augmentin (Amoxicillin-clavulanic), Furoxone (furazolidone) and Cebes (colloidal bismuth subcitrate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2006to Jun 2008
- Phase
- Interventional
- 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
- Informed consent given by the patient
- Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
- Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy
Who cannot join
- Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
- known or suspected hypersensitivity to the medication used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy
Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.
- Conditions
- Treatment of Helicobacter Pylori
- Being tested
- Augmentin (Amoxicillin-clavulanic), Furoxone (furazolidone), Cebes (colloidal bismuth subcitrate), Esso (esomeprazole)
- Keywords
- H.pylori, Triple therapy failure, Quadruple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmentin (Amoxicillin-clavulanic)Drug
Amoxicillin-clavulanic acid 1 gram b.i.d
Furoxone (furazolidone)Drug
furazolidone 200 mg b.i.d
Cebes (colloidal bismuth subcitrate)Drug
colloidal bismuth subcitrate 240 mg b.i.d
Esso (esomeprazole)Drug
esomeprazole 40 mg b.i.d for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Quadruple Therapy | Experimental | Not described Receives: Drug: Augmentin (Amoxicillin-clavulanic); Drug: Furoxone (furazolidone); Drug: Cebes (colloidal bismuth subcitrate); Drug: Esso (esomeprazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of H. pylori infection resistant to triple therapy.
Measured: 6 weeks
Secondary outcomes (1)
Safety of the quadruple therapy
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startOct 2006
- Primary completionJun 2008
- Study completionJun 2008
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 Treatment of Helicobacter PyloriStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Zaigham Abbas, FACG, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520949
- Sponsor's protocol ID
- 609-Med
- Acronym
- QT-Hp
- Status last verified
- Apr 2009
- First submitted
- 24 Aug 2007
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abbas Z, Yakoob J, Abid S, Jafri W, Islam M, Azam Z, Hilal I. Furazolidone, co-amoxiclav, colloidal bismuth subcitrate, and esomeprazole for patients who failed to eradicate Helicobacter pylori with triple therapy. Dig Dis Sci. 2009 Sep;54(9):1953-7. doi: 10.1007/s10620-008-0582-6. Epub 2008 Dec 5.
PubMed 19058002
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy
- ClinicalTrials.gov ID
- NCT00520949
- Acronym / sponsor ID
- QT-Hp / 609-Med
- Conditions
- Treatment of Helicobacter Pylori
- Keywords
- H.pylori, Triple therapy failure, Quadruple therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Aug 2007 (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.
Triple therapy, a combination of proton pump inhibitor with two antibiotics, is the gold standard for anti-Helicobacter pylori treatment. Usual antibiotics are clarithromycin, and either amoxicillin or one of the nitroimidazoles (metronidazole). However, there is an increasing evidence of H. pylori resistance to classical triple therapy. Another reason for this failure being low patient compliance with treatment. A regimen useful in one geographical area may not be effective or practical in another area. The aim of this study was to eradicate H. pylori infection resistant to triple therapy, establish the efficacy and safety of a 14-day therapeutic regimen to eradicate of H. pylori in patients who have failed with the classical triple therapy (omeprazole, clarithromycin and amoxicillin) given for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadruple Therapy | Experimental | Drug: Augmentin (Amoxicillin-clavulanic), Drug: Furoxone (furazolidone), Drug: Cebes (colloidal bismuth subcitrate), Drug: Esso (esomeprazole) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent given by the patient
- Patients known to have H. pylori infection diagnosed by histopathology, rapid urease test and urea breath test
- Failure to respond to classical triple regime of amoxicillin 1gram, clarithromycin 500mg and omeprazole 20mg twice a day for 10-14 days as documented by repeat urea breath test done one month after eradication therapy
Key exclusion criteria (2 listed)
- Evidence of any malignancy, gastric outlet syndrome, history of gastric surgery, chronic liver disease, severe chronic renal failure, or any major co-morbidity.
- known or suspected hypersensitivity to the medication used in the study
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 |
|---|---|---|
| Augmentin (Amoxicillin-clavulanic)Amoxicillin-clavulanic acid 1 gram b.i.d | Drug | Quadruple Therapy |
| Furoxone (furazolidone)furazolidone 200 mg b.i.d | Drug | Quadruple Therapy |
| Cebes (colloidal bismuth subcitrate)colloidal bismuth subcitrate 240 mg b.i.d | Drug | Quadruple Therapy |
| Esso (esomeprazole)esomeprazole 40 mg b.i.d for 14 days | Drug | Quadruple Therapy |
Primary outcome
Eradication of H. pylori infection resistant to triple therapy.
Time frame: 6 weeks
1 secondary outcome
Safety of the quadruple therapy
Time frame: 6 weeks
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 8 Apr 2009.
- Derived from this study: PubMed 19058002Abbas Z, Yakoob J, Abid S, Jafri W, Islam M, Azam Z, Hilal I. Furazolidone, co-amoxiclav, colloidal bismuth subcitrate, and esomeprazole for patients who failed to eradicate Helicobacter pylori with triple therapy. Dig Dis Sci. 2009 Sep;54(9):1953-7. doi: 10.1007/s10620-008-0582-6. Epub 2008 Dec 5.
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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.
Zaigham Abbas, FACG principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmentin (Amoxicillin-clavulanic), Furoxone (furazolidone) and Cebes (colloidal bismuth subcitrate) in people with Treatment of Helicobacter Pylori, run by Aga Khan University at 1 site in Pakistan.
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 2 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 8 Apr 2009. 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 Pakistan. 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.
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 of H. pylori infection resistant to triple therapy. (time frame: 6 weeks). 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 NCT00520949, 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 8 Apr 2009.