Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori
The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: at the end of treatment, one and two months post-treatment ] [ Designated as safety issue: Yes ]
|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. 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
|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|