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Completed

NCT Number: NCT00609557

A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain

This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive duloxetine 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 60-90mg per day of duloxetine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of duloxetine treatment).

Study Hypothesis:

In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 60-90 mg Duloxetine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo(> 30% reduction after Duloxetine treatment).

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Key information

Conditions

Osteoarthritis Arthritis Behavior Behavioral Symptoms Depression Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50-80
  • 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 >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

Treatment and study plan

Duloxetine

Drug

Weeks 0-2 placebo Weeks 2-3 30mg duloxetine Weeks 3-4 60mg duloxetine Weeks 4-12 60-90mg duloxetine Week 13 30 mg duloxetine Week 14 stop

Primary outcomes

  1. Difference in average pain intensity on Brief Pain Inventory

    Time frame: between 2 weeks and 12 weeks

  2. Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC)

    Time frame: Difference between 2 weeks and 12 weeks

Secondary outcomes

  1. Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC)

    Time frame: Difference between 2 and 12 weeks

  2. Difference in role function as assessed by the Sheehan Disability Scales

    Time frame: Difference between 2 and 12 weeks

  3. Difference on observed physical function as assessed by the Aggregated Locomotor Function score

    Time frame: Difference between 2 and 12 weeks

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eli Lilly and Company

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Feb 7, 2008
Registry last updated
Feb 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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