Back to resultsOASIS: Osteoarthritis Sensitivity Integration Study (OASIS)
Primary Purpose
Osteoarthritis, Chronic Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phenotype assessment
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Chronic pain, Central pain
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Duloxetine
Diclofenac
Arm Description
Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
Phenotype assessment prior to and after treatment with topical diclofenac four times daily
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01377038
Brief Title
OASIS: Osteoarthritis Sensitivity Integration Study
Acronym
OASIS
Official Title
Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Chronic Pain
Keywords
Osteoarthritis, Chronic pain, Central pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Description
Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
Phenotype assessment prior to and after treatment with topical diclofenac four times daily
Intervention Type
Other
Intervention Name(s)
Phenotype assessment
Intervention Description
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Primary Outcome Measure Information:
Title
Pain
Time Frame
One month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Phillips, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25580697
Citation
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.
Results Reference
derived
Learn more about this trial
OASIS: Osteoarthritis Sensitivity Integration Study
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