Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori
Information source: Axcan Pharma
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Helicobacter Pylori Infection
Intervention: OBMT (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Axcan Pharma Official(s) and/or principal investigator(s):
Monique Giguère, PhD, Study Director, Affiliation: Axcan Pharma inc
Overall contact:
Monique Giguère, PhD, Phone: 1-800-565-3255, Ext: 2078, Email: mgiguere@axcan.com
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 this trial, subjects with confirmed Helicobacter Pylori infection will
receive Pylera treatment and omeprazole twice daily.
Clinical Details
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
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: H. pylori status confirmed by Urea Breath Test
Secondary outcome: Tolerability
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 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Positive H. pylori status through UBT testing
Exclusion Criteria:
- Documented allergy to any of the drugs contained in the treatment regimen
- Severe renal insufficiency, renal failure orazotemia
- Previous surgery of the upper gastrointestinal tract
- Hepatic failure
- Pre-existing peripheral neuropathies
- Use of any experimental drug within 30 days prior to randomization
Locations and Contacts
Monique Giguère, PhD, Phone: 1-800-565-3255, Ext: 2078, Email: mgiguere@axcan.com
University of Michigan Health System, Ann Arbor, Michigan 48109, United States
McMaster University Medical Center, Division of Gastroenterology, Hamilton, Ontario L8N 3Z5, Canada
Aurora Health Care, Milwaukee, Wisconsin 53233, United States
Additional Information
Starting date: August 2008
Ending date: December 2008
Last updated: July 9, 2008
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