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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611676
• Other study ID #: 04-2664-B01
• Secondary ID: 101722
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2008
• Last updated: January 25, 2008
• Start date: September 2004
• Est. completion date: February 2007

Study information

• Verified date: January 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in average pain intensity on Brief Pain Inventory		Between 2 weeks and 12 weeks	No
Primary	Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)		Between 2 weeks and 12 weeks	No
Secondary	Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)		Between 2 and 12 weeks	No
Secondary	Difference in role function as assessed by the Sheehan Disability Scale		Between 2 and 12 weeks	No
Secondary	Difference in observed physical function as assessed by the Aggravated Locomotor Function Score		Between 2 and 12 weeks	No