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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00609557
First received: January 24, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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).


Condition Intervention Phase
Osteoarthritis
Pain
Drug: duloxetine
Phase 4

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 Duloxetine for Activity-Limiting Osteoarthritis Pain

Resource links provided by NLM:


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: Difference 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: Difference between 2 and 12 weeks ] [ Designated as safety issue: No ]
  • Difference in role function as assessed by the Sheehan Disability Scales [ Time Frame: Difference between 2 and 12 weeks ] [ Designated as safety issue: No ]
  • Difference on observed physical function as assessed by the Aggregated Locomotor Function score [ Time Frame: Difference between 2 and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
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 duloxetine for the next 10 weeks, but they are blind to what they are receiving.
Drug: duloxetine
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

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609557

Sponsors and Collaborators
University of Washington
Eli Lilly and Company
Investigators
Principal Investigator: Mark D. Sullivan, M.D., Ph.D. University of Washington
  More Information

No publications provided

Responsible Party: Mark D. Sullivan, University of Washington
ClinicalTrials.gov Identifier: NCT00609557     History of Changes
Other Study ID Numbers: 04-3386-B01, F1J-MC-X007
Study First Received: January 24, 2008
Last Updated: January 24, 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
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014