Helicobacter Pylori InfectionPhase 3NCT01544517
5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection
A Phase 3 study testing Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) in people with Helicobacter Pylori Infection, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection. 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?
- Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2011to Dec 2011
- Phase
- Phase 3
- 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
- H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.
Who cannot join
- previous treatment for H. pylori infection,
- use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
- gastrointestinal malignancy,
- previous gastro-oesophageal surgery,
- severe concomitant cardiovascular,
- respiratory or endocrine diseases,
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- clinically significant renal or hepatic disease,
- hematologic disorders,
- any other clinically significant medical condition that could increase risk,
- history of allergy to any of the drug used in the study,
- pregnancy or lactation,
- alcohol abuse,
- drug addiction,
- severe neurologic or psychiatric disorders, and
- long-term use of corticosteroids or anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Internistica Clinica e Sperimentale, SUN
Naples, Napoli, 80131
About this study
Official title: Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.
Read the detailed description
The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)
- Keywords
- Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)Drug
Also called proton pump inhibitors
amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
| Study group | Role | What they receive |
|---|---|---|
| 5d-QCT | Experimental | 5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid Receives: Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) |
| 10-day sequential regimen | Active comparator | 5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid Receives: Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication Rate
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
Measured: 1 year
Secondary outcomes (2)
Adverse events
The incidence of adverse events during therapy will be assessed: bad taste, taste alteration, nausea, vomiting, diarrhoea, epigastric pain, glossitis, headache
Measured: 1 year
Costs of either regimen
The costs related to each treatment will be determined
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionDec 2011
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Romano, University of Campania Luigi Vanvitelli
- Investigators
- Marco Romano, MD, Principal investigator, Second University of Naples Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544517
- Sponsor's protocol ID
- EudraCT 2010-02464415
- Status last verified
- Feb 2012
- First submitted
- 22 Feb 2012
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-day Concomitant Versus 10-day Sequential Therapy for Eradication of Helicobacter Pylori Infection: a Randomized Trial of Levofloxacin-based Regimens
- ClinicalTrials.gov ID
- NCT01544517
- Acronym / sponsor ID
- EudraCT 2010-02464415
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, Concomitant therapy, Sequential therapy, levofloxacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Mar 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.
A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.
Detailed description
The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5d-QCT | Experimental | Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid |
| 10-day sequential regimen | Active comparator | Drug: Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.
Key exclusion criteria (15 listed)
- previous treatment for H. pylori infection,
- use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
- gastrointestinal malignancy,
- previous gastro-oesophageal surgery,
- severe concomitant cardiovascular,
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 |
|---|---|---|
| Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)Also: proton pump inhibitorsamoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg | Drug | 10-day sequential regimen, 5d-QCT |
Primary outcome
Eradication Rate
Time frame: 1 year
The eradication rate obtained with the two treatments will be evaluated in the per-protocol and intention-to-treat analyses
2 secondary outcomes
Adverse events
Time frame: 1 year
Costs of either regimen
Time frame: 1 year
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 6 Mar 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.
Marco Romano, MD principal investigator
Second University of Naples Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin) in people with Helicobacter Pylori Infection, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 15 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 6 Mar 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: 1 year). 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 6 Mar 2012.