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

Primary Purpose

Helicobacter Pylori Infection

Status

Withdrawn

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

OBMT

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori infection, Quadruple therapy, Safety, Efficacy, Tolerability, BID dosing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Michigan Health System
Aurora Health Care
McMaster University Medical Center, Division of Gastroenterology

Outcomes

Primary Outcome Measures

H. pylori status confirmed by Urea Breath Test

Secondary Outcome Measures

Tolerability

Full Information

NCT ID

NCT00712413

First Posted

July 8, 2008

Last Updated

February 8, 2017

Sponsor

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00712413

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsor's decision

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2008 (Anticipated)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection, Quadruple therapy, Safety, Efficacy, Tolerability, BID dosing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

OBMT

Other Intervention Name(s)

Pylera

Intervention Description

Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of Pylera, in addition to 1 omeprazole twice daily

Primary Outcome Measure Information:

Title

H. pylori status confirmed by Urea Breath Test

Time Frame

at 6 and 10 weeks following treatment

Secondary Outcome Measure Information:

Title

Tolerability

Time Frame

at the end of treatment, one and two months post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monique Giguère, PhD

Organizational Affiliation

Axcan Pharma inc

Official's Role

Study Director

Facility Information:

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Aurora Health Care

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53233

Country

United States

Facility Name

McMaster University Medical Center, Division of Gastroenterology

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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