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Osteoarthritis | OASIS: Osteoarthritis Sensitivity Integration Study

Osteoarthritis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Osteoarthritis

Chronic Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Phenotype assessmentQuantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Withdrawn

Start Date: September 2011

Completed Date: July 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Pain

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Kristine Phillips, MD, PhD

Lead Sponsor: University of Michigan

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01377038

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