- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00611676
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).
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Weeks 0-2: placebo.
Weeks 2-3: 75 mg Venlafaxine.
Weeks 3-4: 150 mg Venlafaxine.
Weeks 4-12: 150-225 mg Venlafaxine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in average pain intensity on Brief Pain Inventory
Time Frame: Between 2 weeks and 12 weeks
|
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
|
Between 2 weeks and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)
Time Frame: Between 2 and 12 weeks
|
Between 2 and 12 weeks
|
Difference in role function as assessed by the Sheehan Disability Scale
Time Frame: Between 2 and 12 weeks
|
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
|
Between 2 and 12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark D. Sullivan, MD, PhD, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- 04-2664-B01
- 101722
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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