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

January 24, 2008 updated by: University of Washington

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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: Difference between 2 weeks and 12 weeks
Difference 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: Difference between 2 and 12 weeks
Difference between 2 and 12 weeks
Difference in role function as assessed by the Sheehan Disability Scales
Time Frame: Difference between 2 and 12 weeks
Difference between 2 and 12 weeks
Difference on observed physical function as assessed by the Aggregated Locomotor Function score
Time Frame: Difference between 2 and 12 weeks
Difference between 2 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eli Lilly and Company

Investigators

  • Principal Investigator: Mark D. Sullivan, M.D., Ph.D., University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 24, 2008

First Submitted That Met QC Criteria

January 24, 2008

First Posted (Estimate)

February 7, 2008

Study Record Updates

Last Update Posted (Estimate)

February 7, 2008

Last Update Submitted That Met QC Criteria

January 24, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-3386-B01
  • F1J-MC-X007

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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