OASIS: Osteoarthritis Sensitivity Integration Study

University of Michigan

Status: Withdrawn

Conditions: Osteoarthritis; Chronic Pain

Treatments: Other: Phenotype assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT01377038

2011 HUM00044644

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Duloxetine

Active Comparator group

Description:

Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.

Treatment:

Other: Phenotype assessment

Diclofenac

Active Comparator group

Description:

Phenotype assessment prior to and after treatment with topical diclofenac four times daily

Treatment:

Other: Phenotype assessment