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

NCT ID: NCT01177241

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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CLBP

No interventions assigned to this group

CLBP OU

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* chronic low back pain

Exclusion Criteria

* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NEMA Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Joseph Pergolizzi, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CYP450CLBP1

Identifier Type: -

Identifier Source: org_study_id

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