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NCT01177241 Clinical Trial

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

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01177241
Other study ID # CYP450CLBP1
Secondary ID
Status Completed
Phase N/A
First received August 5, 2010
Last updated April 28, 2012
Start date September 2010
Est. completion date January 2011

Study information
Verified date April 2012
Source NEMA Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 10000
Est. completion date January 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- chronic low back pain

Exclusion Criteria:

- pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NEMA Research, Inc.
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