OASIS: Osteoarthritis Sensitivity Integration Study

Chronic Pain Clinical Trial

— OASIS  

Official title:

Central Pain Mechanisms in Osteoarthritis: A Longitudinal Cohort

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01377038
• Other study ID #: 2011 HUM00044644
• Status: Withdrawn
• Phase: N/A
• First received: June 16, 2011
• Last updated: October 24, 2016
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

Other:
• Phenotype assessment
Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		One month	No