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

NCT00609557 | Completed Phase 4

• 2 other identifiers: 04-3386-B01F1J-MC-X007
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Osteoarthritis; Pain

Keywords

osteoarthritis pain; activity limitation; antidepressant; depression; single-blind

Outcome Measures

Primary Outcomes (2)

• Difference in average pain intensity on Brief Pain Inventory

  between 2 weeks and 12 weeks

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

  Difference between 2 weeks and 12 weeks

Secondary Outcomes (3)

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

  Difference between 2 and 12 weeks

• Difference in role function as assessed by the Sheehan Disability Scales

  Difference between 2 and 12 weeks

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

  Difference between 2 and 12 weeks

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

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

A

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Osteoarthritis; Pain; Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark D. Sullivan, M.D., Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 7, 2008
• Study Start: September 1, 2004
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: February 7, 2008

Record last verified: 2008-01