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

Status:	Withdrawn
Conditions:	Infectious Disease, Infectious Disease, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/10/2017
Start Date:	August 2008
End Date:	December 2008

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

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.

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. Urea breath test (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

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

We found this trial at

sites

University of Michigan Health System

1500 E Medical Center Dr
Ann Arbor, Michigan 48109

(734) 936-4000