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

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ClinicalTrials.gov Identifier: NCT01177254
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.

Brief Summary:
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 or disease
Chronic Low Back Pain

Study Type : Observational
Actual Enrollment : 10000 participants
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
Study Start Date : September 2010
Primary Completion Date : December 2010
Study Completion Date : February 2011

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01177254     History of Changes
Other Study ID Numbers: CYP450OA1
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Joseph Pergolizzi, MD, NEMA Research, Inc.:
retrospective chronic low back pain

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