Status:
WITHDRAWN
Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori
Lead Sponsor:
Forest Laboratories
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 signat...
Eligibility Criteria
Inclusion
- Positive H. pylori status through UBT testing
Exclusion
- Documented allergy to any of the drugs contained in the treatment regimen
- Severe renal insufficiency, renal failure or azotemia
- Previous surgery of the upper gastrointestinal tract
- Hepatic failure
- Pre-existing peripheral neuropathies
- Use of any experimental drug within 30 days prior to randomization
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00712413
Start Date
August 1 2008
End Date
December 1 2008
Last Update
February 9 2017
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
2
Aurora Health Care
Milwaukee, Wisconsin, United States, 53233
3
McMaster University Medical Center, Division of Gastroenterology
Hamilton, Ontario, Canada, L8N 3Z5