Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Eli Lilly and Company1 site in 1 country231 target enrollmentNovember 2006

ConditionsOsteoarthritis Knee Pain

InterventionsDuloxetine placebo

DrugsDuloxetine placebo

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Osteoarthritis Knee Pain
Sponsor: Eli Lilly and Company
Enrollment: 231
Locations: 1
Primary Endpoint: Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.

Registry

clinicaltrials.gov

Start Date

November 2006

End Date

October 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•Male or female outpatients with osteoarthritis knee pain.

Exclusion Criteria

•Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
•Acute liver injury (such as hepatitis) or severe cirrhosis.
•Previous exposure to duloxetine.
•Body Mass Index (BMI) over
•Major depressive disorder.
•Daily use of narcotics.

Arms & Interventions

A

duloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks

Intervention: Duloxetine

B

placebo daily (QD), by mouth (PO) for 13 weeks

Intervention: placebo

Outcomes

Primary Outcomes

Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary

Time Frame: Over 13 Weeks

This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).

Secondary Outcomes

Patient Global Impression of Improvement at 13 Week Endpoint(13 Weeks)
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score(Baseline and 13 Weeks)
Weekly Change From Baseline in the 24-Hour Worst Pain Score(Over 13 Weeks)
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference(Baseline and 13 Weeks)
Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings(Over 13 Weeks)
Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase(Over 13 Weeks)
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale(Baseline and 13 Weeks)
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase(Baseline and 13 Weeks)
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight(Baseline and 13 Weeks)