NCT00712413

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3

Geographic Reach
2 countries

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

July 8, 2008

Last Update Submit

February 8, 2017

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infectionQuadruple therapySafetyEfficacyTolerabilityBID dosing

Outcome Measures

Primary Outcomes (1)

  • H. pylori status confirmed by Urea Breath Test

    at 6 and 10 weeks following treatment

Secondary Outcomes (1)

  • Tolerability

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

Interventions

OBMTDRUG

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

Also known as: Pylera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53233, United States

Location

McMaster University Medical Center, Division of Gastroenterology

Hamilton, Ontario, L8N 3Z5, Canada

Location

Study Officials

  • Monique Giguère, PhD

    Axcan Pharma inc

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

CA(1)US(2)