- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669955
Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Efficacy and Safety of Quadruple Therapy by Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Given X 10 Days With Omeprazole in Eradication of Helicobacter Pylori: A Comparison to Omeprazole, Amoxicillin and Clarithromycin Given X 7 Days
Study Overview
Status
Conditions
Detailed Description
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14.
Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bath, United Kingdom
- Dr. I. Orpen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Positive H. Pylori status;
- Presence of upper gastro-intestinal symptoms;
- Mental and legal ability to sign informed consent.
Exclusion Criteria:
- Previous surgery of the GI tract;
- Clinically significant impairment of renal or hepatic function;
- Severe unstable cardiovascular, pulmonary or endocrine disease;
- Barrett's oesophagus or high-grade dysplasia;
- Dysphagia or vomiting as major symptoms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OAC 7 days
Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily
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Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID
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Experimental: OBMT 10 days
OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily.
Omeprazole 20 mg is administered twice daily.
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Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helicobacter Pylori Eradication Confirmed by Urea Breath Test
Time Frame: Week 6 and week 10 follow-up visits
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H. pylori Eradication defined as a negative C13-UBT (urea breath test) result at both Week 6 and Week 10 follow-up visits.
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Week 6 and week 10 follow-up visits
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Experiencing Treatment Emergent Adverse Events.
Time Frame: at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.
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A treatment-emergent adverse event is defined as an event not present prior to exposure to the study medication or any event already present that worsens in either intensity or frequency following exposure to study medication up to 30 days after study discontinuation. All safety analysis based on the safety population. |
at the end of treatment (day 8-14), week 6 and wek 10 follow-up visits.
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H. Pylori Eradication and Presence or Past History of Peptic Ulcers
Time Frame: Week 6 and week 10 follow-up visits
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Eradication rates in the subset of patients with peptic ulcer (current or past history) at baseline are reported based on the per protocol population.
Eradication must be confirmed at week 6 and week 10 by a negative Urea Breath Test conducted within the allocated windows.
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Week 6 and week 10 follow-up visits
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Clarithromycin Resistance
Time Frame: Measured at baseline
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Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to clarithromycin at baseline.
Resistance to clarithromycin defined as Minimum Inhibitory Concentration (MIC) of 1 ug/ml and above
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Measured at baseline
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Metronidazole Resistance
Time Frame: Measured at baseline
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Eradication rates in subset of patients infected with a bacterial strain confirmed as resistant to metronidazole at baseline.
Resistance to metronidazole defined as Minimum Inhibitory Concentration (MIC) above 8 ug/ml
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Measured at baseline
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Overall Compliance to Study Medications
Time Frame: At the end of the treatment phase (days 8-14)
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Overall compliance: number of capsules dispensed - number of capsules returned/Number of prescribed capsules X 100.
Percentages based on safety population
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At the end of the treatment phase (days 8-14)
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Number of Patients With Bismuth Plasma Concentrations Above the Toxic Level
Time Frame: Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only
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Tolerability of OBMT with respect to plasma bismuth concentrations: number of patients with bismuth concentrations above the toxic level (50 ug per liter)
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Baseline (both arms), end of treatment (Day 11-14) and end of study (Day 70) OBMT arm only
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Monique Giguère, PhD, Axcan Pharma inc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Helicobacter Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antacids
- Metronidazole
- Amoxicillin
- Clarithromycin
- Omeprazole
- Bismuth
- Tetracycline
- Bismuth tripotassium dicitrate
Other Study ID Numbers
- PYLHp07-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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