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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 22, 2006 | ||||
| Last Updated Date | November 22, 2006 | ||||
| Start Date ICMJE | July 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
13C urea breath test, upper endoscopy, histology, rapid urease test assessment | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
bacterial culture, and antibiotic resistance assessment | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial | ||||
| Official Title ICMJE | Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial | ||||
| Brief Summary | To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease. |
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| Detailed Description | Background: Antimicrobial resistance has decreased eradication rates for H. pylori worldwide. Objective: To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease. Design: Placebo-controlled trial. Setting: Two Italian Hospitals between September 2003 and April 2006. Patients: 300 dyspeptic or peptic ulcer patients Measurements: 13C urea breath test, upper endoscopy, histology, rapid urease test, bacterial culture, and antibiotic resistance assessment. Intervention: 10-day sequential regimen (pantoprazole 40 mg, amoxicillin 1 g plus placebo for the first 5 days, followed by pantoprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining 5 days) in 150 patients or standard 10-day therapy (pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g) in 150 patients. All drugs were given twice daily. Results: There were 295 patients (Intent to treat) of whom 91% (95% CI: 86.5–95.7) had successful eradication with sequential therapy compared to 78% (95% CI: 71.2–84.5) for standard therapy (difference: 13.3%; 95%). The sequential therapy was significantly more effective in patients with clarithromycin resistant strains (88.9% patients vs. 28.6%; P = 0.0034). The incidence of major and minor side effects did not differ between therapy groups (17% vs. 17%). Limitations: Follow-up was incomplete in 4.6% and 2.7% patients in sequential and standard therapy, respectively. The higher efficacy of sequential regimen should be confirmed outside Italy. Conclusions: Sequential therapy is superior to conventional therapy for the eradication of H. pylori and it is significantly more effective in patients harbouring clarithromycin resistant strains. The incidence side effects did not differ between therapy groups. |
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| Study Phase | Phase II, Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Helicobacter Pylori Infection | ||||
| Intervention ICMJE | Drug: Placebo amoxicillin pantoprazole clarithromycin tinidazole | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | February 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00403364 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1112/2006, No grant received | ||||
| Study Sponsor ICMJE | St. Orsola Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | St. Orsola Hospital | ||||
| Verification Date | November 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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