Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01177241
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : May 1, 2012
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: Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources


Information from the National Library of Medicine

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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
Patients with chronic low back pain on opioids

Inclusion Criteria:

  • chronic low back pain

Exclusion Criteria:

  • pregnancy

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc. Identifier: NCT01177241     History of Changes
Other Study ID Numbers: CYP450CLBP1
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:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms