OASIS: Osteoarthritis Sensitivity Integration Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Nuvo Research Inc.
Information provided by (Responsible Party):
Kristine Phillips, University of Michigan
ClinicalTrials.gov Identifier:
NCT01377038
First received: June 16, 2011
Last updated: June 5, 2015
Last verified: June 2015
  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
Other: Phenotype assessment
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:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Pain [ Time Frame: One month ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Duloxetine
Phenotype assessment prior to and after treatement with duloxetine 20-30 mg oral daily for eight weeks.
Other: Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
Active Comparator: Diclofenac
Phenotype assessment prior to and after treatment with topical diclofenac four times daily
Other: Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377038

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Merck Sharp & Dohme Corp.
Nuvo Research Inc.
Investigators
Principal Investigator: Kristine Phillips, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Kristine Phillips, Associate 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: June 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Osteoarthritis
Chronic pain
Central pain

Additional relevant MeSH terms:
Chronic Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Rheumatic Diseases
Signs and Symptoms
Diclofenac
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antidepressive Agents
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 03, 2015