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Trial record 1 of 1 for:    NCT00611676
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A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT00611676
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : February 11, 2008
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
University of Washington

Tracking Information
First Submitted Date  ICMJE January 25, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date February 11, 2008
Study Start Date  ICMJE September 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • 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: Between 2 weeks and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2008)
  • Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC) [ Time Frame: Between 2 and 12 weeks ]
  • Difference in role function as assessed by the Sheehan Disability Scale [ Time Frame: Between 2 and 12 weeks ]
  • Difference in observed physical function as assessed by the Aggravated Locomotor Function Score [ Time Frame: Between 2 and 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
Official Title  ICMJE A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
Brief Summary

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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Pain
Intervention  ICMJE Drug: Venlafaxine
Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.
Study Arms  ICMJE Experimental: A
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
Intervention: Drug: Venlafaxine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2008)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00611676
Other Study ID Numbers  ICMJE 04-2664-B01
101722
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark D. Sullivan, MD, PhD, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Mark D. Sullivan, MD, PhD University of Washington
PRS Account University of Washington
Verification Date January 2008

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