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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT01177267
First received: August 5, 2010
Last updated: April 28, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Osteoarthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NEMA Research, Inc.:

Estimated Enrollment: 10000
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

retrospective database analysis

Criteria

Inclusion Criteria:

  • osteoarthritis

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177267

Sponsors and Collaborators
NEMA Research, Inc.
Investigators
Principal Investigator: Joseph Pergolizzi, MD NEMA Research
  More Information

No publications provided

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01177267     History of Changes
Other Study ID Numbers: CYP450OA3
Study First Received: August 5, 2010
Last Updated: April 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NEMA Research, Inc.:
retrospective database analysis in osteoarthritis patients

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013