Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2011-09-30
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Duloxetine
Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Diclofenac
Phenotype assessment prior to and after treatment with topical diclofenac four times daily
Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Interventions
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Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Eligibility Criteria
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Inclusion Criteria
* Males and females age greater than 50 years at time of screening
Exclusion Criteria
* History of anemia
* Allergy or intolerance of drug intervention
* Inability to participate in outcome measures
50 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Kristine Phillips
Associate Professor
Principal Investigators
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Kristine Phillips, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Murphy SL, Lyden AK, Kratz AL, Fritz H, Williams DA, Clauw DJ, Gammaitoni AR, Phillips K. Characterizing Pain Flares From the Perspective of Individuals With Symptomatic Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2015 Aug;67(8):1103-11. doi: 10.1002/acr.22545.
Other Identifiers
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2011 HUM00044644
Identifier Type: -
Identifier Source: org_study_id