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

February 8, 2017 updated by: Forest Laboratories

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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. 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

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Center, Division of Gastroenterology
  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
H. pylori status confirmed by Urea Breath Test
Time Frame: at 6 and 10 weeks following treatment
at 6 and 10 weeks following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability
Time Frame: at the end of treatment, one and two months post-treatment
at the end of treatment, one and two months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Monique Giguère, PhD, Axcan Pharma inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

July 8, 2008

First Submitted That Met QC Criteria

July 9, 2008

First Posted (Estimate)

July 10, 2008

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PYLHp08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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