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

• Status: Withdrawn
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axcan Pharma; Forest Laboratories
• Treatments: Omeprazole

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 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