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| Sponsor: | Axcan Pharma |
|---|---|
| Information provided by: | Axcan Pharma |
| ClinicalTrials.gov Identifier: | NCT00669955 |
Purpose
This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Infections |
Drug: Omeprazole, amoxicillin, clarithromycin Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
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.
| Enrollment: | 440 |
| Study Start Date: | June 2008 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: OAC 7 days
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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Drug: Omeprazole, amoxicillin, clarithromycin
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 a day. Omeprazole 20 mg is administered twice a day,
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Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
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 Name: Pylera
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Dr. Monique Giguere, Axcan Pharma inc. |
| ClinicalTrials.gov Identifier: | NCT00669955 History of Changes |
| Other Study ID Numbers: | PYLHp07-01 |
| Study First Received: | April 29, 2008 |
| Results First Received: | June 21, 2010 |
| Last Updated: | August 3, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: National Health Service; Spain: Ethics Committee; Spain: Ministry of Health; Poland: Ministry of Health; Ireland: Irish Medicines Board; Italy: National Bioethics Committee; France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board (MEB) |
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H. Pylori Quadruple therapy Eradication rate |
Multinational trial Resistance to antibiotics Subjects with confirmed Helicobacter Pylori infection |
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Helicobacter Infections Gram-Negative Bacterial Infections Bacterial Infections Tetracycline Clarithromycin Amoxicillin Bismuth tripotassium dicitrate Metronidazole Omeprazole Bismuth Protein Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Antacids Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Anti-Ulcer Agents Gastrointestinal Agents |