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

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

Chronic Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Cytochrome P450 Pharmacokinetic DDIs Among Patients With Chronic Low Back Pain Taking Opioids

Resource links provided by NLM:

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

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)


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
Patients with chronic low back pain on opioids

Inclusion Criteria:

  • chronic low back pain

Exclusion Criteria:

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

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc. Identifier: NCT01177241     History of Changes
Other Study ID Numbers: CYP450CLBP1 
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
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on May 30, 2016