Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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 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
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, see Learn About Clinical Studies.

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
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014