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

Forest Laboratories

Status and phase: Withdrawn; Phase 3

Conditions: Helicobacter Pylori Infection

Treatments: Drug: OBMT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00712413

PYLHp08-01

Details and patient eligibility

About

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.

Full 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. 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)