OASIS: Osteoarthritis Sensitivity Integration Study

Not Applicable

Withdrawn

• Conditions: Osteoarthritis; Chronic Pain
• Interventions: Other: Phenotype assessment

• Registration Number: NCT01377038
• Lead Sponsor: University of Michigan

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Study Start: 2011-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Diclofenac	Phenotype assessment	Phenotype assessment prior to and after treatment with topical diclofenac four times daily
Duloxetine	Phenotype assessment	Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.

Primary Outcome Measures

Name	Time	Method
Pain	One month

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States