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

Withdrawn before enrolling · Phase 3

Conditions studied: Helicobacter Pylori Infection

In brief

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.

Key facts

Study ID

NCT00712413

Run by

Forest Laboratories

People needed

0

Starts

2008-08-01

Expected to finish

2008-12-01

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Positive H. pylori status through UBT testing

You may not qualify if…

• 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

Where it is running

• University of Michigan Health System — Ann Arbor, Michigan, United States
• Aurora Health Care — Milwaukee, Wisconsin, United States
• McMaster University Medical Center, Division of Gastroenterology — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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