A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain - Full Text View

Sponsor:	University of Washington
Collaborator:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00611676

Purpose

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).

Condition	Intervention	Phase
Osteoarthritis Pain	Drug: Venlafaxine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	18
Study Start Date:	September 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	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.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611676

Sponsors and Collaborators

University of Washington

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Principal Investigator:

Mark D. Sullivan, MD, PhD

University of Washington

More Information

No publications provided

Responsible Party:	Mark D. Sullivan, MD, PhD, University of Washington
ClinicalTrials.gov Identifier:	NCT00611676 History of Changes
Other Study ID Numbers:	04-2664-B01, 101722
Study First Received:	January 25, 2008
Last Updated:	January 25, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

osteoarthritis pain
activity limitation
antidepressant
depression
single-blind

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012