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

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ClinicalTrials.gov Identifier: NCT00712413
Recruitment Status : Withdrawn (Sponsor's decision)
First Posted : July 10, 2008
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: OBMT Phase 3

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole


Intervention Details:
  • Drug: OBMT
    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
    Other Name: Pylera


Primary Outcome Measures :
  1. H. pylori status confirmed by Urea Breath Test [ Time Frame: at 6 and 10 weeks following treatment ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: at the end of treatment, one and two months post-treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Forest Laboratories
Investigators
Study Director: Monique Giguère, PhD Axcan Pharma inc

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00712413     History of Changes
Other Study ID Numbers: PYLHp08-01
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Keywords provided by Forest Laboratories:
Helicobacter pylori infection
Quadruple therapy
Safety
Efficacy
Tolerability
BID dosing

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action