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Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions(DDI) Among Osteoarthritis Patients

Sponsor
NEMA Research, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01177267
Collaborator
(none)
10,000
Enrollment
4
Duration (Months)

Study Details

Study Description

Brief Summary

Using a retrospective database analysis, OA patients taking at least one CYP450-metabolized opioid (codeine, fentanyl, hydrocodone, methadone, oxycodone, or tramadol) and at least one other prescription drug metabolized via the CYP450 system were evaluated for an incident drug-drug exposure (DDE), which places them at risk for experiencing a pharmacokinetic drug-drug interaction (DDI).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Prevalence of Potential Cytochrome P450 Pharmacokinetic Incident Drug-Drug Interactions Among Osteoarthritis Patients Taking Opioid Analgesics and Associated Economic Outcomes
    Study Start Date :
    Sep 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Jan 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • osteoarthritis
      Exclusion Criteria:
      • pregnancy

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • NEMA Research, Inc.

      Investigators

      • Principal Investigator: Joseph Pergolizzi, MD, NEMA Research

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
      ClinicalTrials.gov Identifier:
      NCT01177267
      Other Study ID Numbers:
      • CYP450OA3
      First Posted:
      Aug 6, 2010
      Last Update Posted:
      May 1, 2012
      Last Verified:
      Apr 1, 2012
      Keywords provided by Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
      retrospective database analysis in osteoarthritis patients
      Additional relevant MeSH terms:
      Osteoarthritis

      Study Results

      No Results Posted as of May 1, 2012