We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177254
First Posted: August 6, 2010
Last Update Posted: May 1, 2012
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.
Information provided by (Responsible Party):
Joseph Pergolizzi, MD, NEMA Research, Inc.
  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:


Further study details as provided by Joseph Pergolizzi, MD, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Joseph Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
ClinicalTrials.gov Identifier: NCT01177254     History of Changes
Other Study ID Numbers: CYP450OA1
First Submitted: August 5, 2010
First Posted: August 6, 2010
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