Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Pilot Study Assessing the Safety, Tolerability, Compliance and Efficacy of Twice Daily Dosed Pylera Plus Omeprazole as a First Line Treatment of Helicobacter Pylori Infection|
- H. pylori status confirmed by Urea Breath Test [ Time Frame: at 6 and 10 weeks following treatment ]
- Tolerability [ Time Frame: at the end of treatment, one and two months post-treatment ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2008|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
This study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc).
Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14.
Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712413
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|United States, Wisconsin|
|Aurora Health Care|
|Milwaukee, Wisconsin, United States, 53233|
|McMaster University Medical Center, Division of Gastroenterology|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Study Director:||Monique Giguère, PhD||Axcan Pharma inc|