Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori - Full Text View

Sponsored by:	Axcan Pharma
Information provided by:	Axcan Pharma
ClinicalTrials.gov Identifier:	NCT00712413

Purpose

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.

Condition	Intervention	Phase
Helicobacter Pylori Infection	Drug: OBMT	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Omeprazole

U.S. FDA Resources

Further study details as provided by Axcan Pharma:

Primary Outcome Measures:

H. pylori status confirmed by Urea Breath Test [ Time Frame: at 6 and 10 weeks following treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability [ Time Frame: at the end of treatment, one and two months post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Omeprazole 20 mg bid, 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

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. 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 orazotemia
Previous surgery of the upper gastrointestinal tract
Hepatic failure
Pre-existing peripheral neuropathies
Use of any experimental drug within 30 days prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712413

Locations

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

Sponsors and Collaborators

Axcan Pharma

Investigators

Study Director:

Monique Giguère, PhD

Axcan Pharma inc

More Information

No publications provided

Responsible Party:	Axcan Pharma inc. ( Monique Giguère, PhD, Programs Director, Clinical Development )
Study ID Numbers:	PYLHp08-01
Study First Received:	July 8, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00712413 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Axcan Pharma:

Helicobacter pylori infection
Quadruple therapy
Safety

Efficacy
Tolerability
BID dosing

Study placed in the following topic categories:

Metronidazole
Bismuth tripotassium dicitrate
Omeprazole
Tetracycline
Bismuth

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on September 03, 2009