A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain
This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).
In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(> 30% reduction after Duloxetine treatment).
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain|
- Difference in average pain intensity on Brief Pain Inventory [ Time Frame: between 2 weeks and 12 weeks ]
- Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC) [ Time Frame: Difference between 2 weeks and 12 weeks ]
- Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC) [ Time Frame: Difference between 2 and 12 weeks ]
- Difference in role function as assessed by the Sheehan Disability Scales [ Time Frame: Difference between 2 and 12 weeks ]
- Difference on observed physical function as assessed by the Aggregated Locomotor Function score [ Time Frame: Difference between 2 and 12 weeks ]
|Study Start Date:||September 2004|
|Study Completion Date:||February 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
All subjects receive placebo for the first two weeks and then duloxetine for the next 10 weeks, but they are blind to what they are receiving.
Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609557
|Principal Investigator:||Mark D. Sullivan, M.D., Ph.D.||University of Washington|