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Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.
ClinicalTrials.gov Identifier:
NCT01177254
First received: August 5, 2010
Last updated: April 28, 2012
Last verified: April 2012
History of Changes
  Purpose

Using a retrospective analysis of a large commercial claims database and a Medicare database, the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450 enzyme system, concomitant with other CYP450-metabolized drug(s).


Condition
Chronic Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 10000
Study Start Date: September 2010
Study Completion Date: February 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:   Yes
Sampling Method:   Non-Probability Sample
Study Population

retrospective chronic low back pain patients taking opioids

Criteria

Inclusion Criteria:

  • chronic low back pain

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01177254     History of Changes
Other Study ID Numbers: CYP450OA1
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 chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Osteoarthritis
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013