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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) vs triple therapy (amoxicillin, clarithromycin and omeprazole) 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. Approximately one month and two months after treatment, a urea breath test will be performed to confirm eradication.
| Condition | Intervention | Phase |
|---|---|---|
|
Helicobacter Infections |
Drug: OBMT Drug: OAC |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 400 |
| 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 |
|---|---|
|
2: Active Comparator
Triple therapy, consisting of Omeprazole, Amoxicilin and Clarithromycin given for 7 days
|
Drug: OAC
given bid for 7 days
|
|
1: Experimental
OBMT (Pylera)
|
Drug: OBMT
QID for 10 days
|
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 Urea Breath Test, 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: | Axcan Pharma inc. ( Dr. Monique Giguere ) |
| Study ID Numbers: | PYLHp07-01 |
| Study First Received: | April 29, 2008 |
| Last Updated: | November 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00669955 History of Changes |
| 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) |
|
H. Pylori Quadruple therapy Eradication rate |
Multinational trial Resistance to antibiotics Subjects with confirmed Helicobacter Pylori infection |
|
Bacterial Infections Communicable Diseases Helicobacter Infections Infection Gram-Negative Bacterial Infections |
