Study Stopped
Funding
OASIS: Osteoarthritis Sensitivity Integration Study
OASIS
Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 26, 2016
October 1, 2016
3.8 years
June 16, 2011
October 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain
One month
Study Arms (2)
Duloxetine
ACTIVE COMPARATORPhenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
Diclofenac
ACTIVE COMPARATORPhenotype assessment prior to and after treatment with topical diclofenac four times daily
Interventions
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
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.
PMID: 25580697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristine Phillips, MD, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 20, 2011
Study Start
September 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
October 26, 2016
Record last verified: 2016-10