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Clinical Trials/NCT01377038
NCT01377038
Withdrawn
Not Applicable

Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort

University of Michigan1 site in 1 countrySeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Michigan
Locations
1
Primary Endpoint
Pain
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief Summary

The primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. Secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.

Detailed Description

This is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain. The study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. Subjects will be randomized only after all entry criteria have been met. These individuals will be evaluated at baseline, and then followed longitudinally following enrollment.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kristine Phillips

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with knee osteoarthritis as defined by American College of Rheumatology (ACR) criteria
  • Males and females age greater than 50 years at time of screening

Exclusion Criteria

  • History of chronic kidney disease or moderate to severe hepatic impairment
  • History of anemia
  • Allergy or intolerance of drug intervention
  • Inability to participate in outcome measures

Outcomes

Primary Outcomes

Pain

Time Frame: One month

Study Sites (1)

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