OASIS: Osteoarthritis Sensitivity Integration Study
This study is currently recruiting participants.
Verified January 2013 by University of Michigan
Sponsor:
University of Michigan
Collaborators:
Merck
Nuvo Research Inc.
Information provided by (Responsible Party):
Kristine Phillips, University of Michigan
ClinicalTrials.gov Identifier:
NCT01377038
First received: June 16, 2011
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Chronic Pain |
Drug: duloxetine, diclofenac |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Central Pain Mechanisms in Osteoarthritis: A Randomized, Double-blind, Crossover Study to Evaluate the Effectiveness of Topical Diclofenac Versus Duloxetine for Chronic Osteoarthritis Pain |
Resource links provided by NLM:
Drug Information available for:
Diclofenac sodium
Diclofenac potassium
Diclofenac
Duloxetine
Duloxetine hydrochloride
U.S. FDA Resources
Further study details as provided by University of Michigan:
Primary Outcome Measures:
- Pain [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377038
Contacts
| Contact: Virginia Leone, MA | 734-615-6910 | vleone@umich.edu |
| Contact: Craig Urwin | 734-998-7110 | craijose@med.umich.edu |
Locations
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Virginia Leone vleone@umich.edu | |
| Contact: Craig Urwin craijose@med.umich.edu | |
| Principal Investigator: Kristine Phillips, MD, PhD | |
Sponsors and Collaborators
University of Michigan
Merck
Nuvo Research Inc.
Investigators
| Principal Investigator: | Kristine Phillips, MD, PhD | University of Michigan |
More Information
No publications provided
| Responsible Party: | Kristine Phillips, Assistant Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01377038 History of Changes |
| Other Study ID Numbers: | 2011 HUM00044644, 1K23AR060241-01, UL1RR024986 |
| Study First Received: | June 16, 2011 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Osteoarthritis Chronic pain Central pain |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Diclofenac Duloxetine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Serotonin Agents Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013