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Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

Information source: Axcan Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: OBMT (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Axcan Pharma

Official(s) and/or principal investigator(s):
Monique Giguère, PhD, Study Director, Affiliation: Axcan Pharma inc


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: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

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
Last updated: December 17, 2008

Page last updated: August 23, 2015

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