A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain
NCT00611676
ABOUT THIS STUDY
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- 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.
- 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
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Descriptive Information | ||||
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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 |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |