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A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
This study has been completed.
Study NCT00611676   Information provided by University of Washington
First Received: January 25, 2008   No Changes Posted

January 25, 2008
January 25, 2008
September 2004
February 2007   (final data collection date for primary outcome measure)
  • Difference in average pain intensity on Brief Pain Inventory [ Time Frame: Between 2 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC) [ Time Frame: Between 2 weeks and 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC) [ Time Frame: Between 2 and 12 weeks ] [ Designated as safety issue: No ]
  • Difference in role function as assessed by the Sheehan Disability Scale [ Time Frame: Between 2 and 12 weeks ] [ Designated as safety issue: No ]
  • Difference in observed physical function as assessed by the Aggravated Locomotor Function Score [ Time Frame: Between 2 and 12 weeks ] [ Designated as safety issue: No ]
Same as current
 
A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive Venlafaxine 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 150-225 mg per day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment).

Study Hypothesis:

In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo (more than 30% reduction after Venlafaxine treatment).

 
Phase IV
Interventional
Treatment, Non-Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Osteoarthritis
  • Pain
Drug: Venlafaxine
Experimental: All subjects receive placebo for the first two weeks and then Venlafaxine for the next 10 weeks, but they are blind to what they are receiving
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
18
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 50 - 80 years
  • Physician diagnosis of OA in hip, knee or spine
  • Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain more than 5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs (This will identify an OA group with significant psychological distress and a desire for treatment).
  • Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation.

Exclusion Criteria:

  • Cannot read and write English
  • Significant cognitive impairment
  • History of psychosis or mania
  • Current suicidal ideation
  • Current substance abuse or dependence
  • Current use of opioids or any antidepressant medication
  • Use of investigational drug within the past month
Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00611676
Mark D. Sullivan, MD, PhD, University of Washington
04-2664-B01, 101722
University of Washington
Wyeth
Principal Investigator: Mark D. Sullivan, MD, PhD University of Washington
University of Washington
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP