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

This study has been withdrawn prior to enrollment.
(Sponsor's decision)
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00712413
First received: July 8, 2008
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  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 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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:
    Drug: OBMT
    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
    Other Name: Pylera
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: Monique Giguère, PhD, Programs Director, Clinical Development, Axcan Pharma inc.
ClinicalTrials.gov Identifier: NCT00712413     History of Changes
Other Study ID Numbers: PYLHp08-01
Study First Received: July 8, 2008
Last Updated: December 17, 2008
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

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Omeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013