Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Eli Lilly and Company1 site in 1 country256 target enrollmentFebruary 2007

ConditionsOsteoarthritis Knee Pain

InterventionsDuloxetine Placebo

DrugsDuloxetine Placebo

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Osteoarthritis Knee Pain
Sponsor: Eli Lilly and Company
Enrollment: 256
Locations: 1
Primary Endpoint: Change in Brief Pain Inventory (BPI) 24-hour Average Rating
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

February 2007

End Date

May 2008

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

•Serious 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.
•Previous exposure to duloxetine.

Arms & Interventions

A

Intervention: Duloxetine

B

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Brief Pain Inventory (BPI) 24-hour Average Rating

Time Frame: Baseline, Week 4, Week 7, Week 13

A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.

Secondary Outcomes

Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)(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 Universities Osteoarthritis Index (WOMAC) Pain Subscale(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)(Baseline and 13 Weeks)
Number of Participants Who Responded to Treatment at 13 Week Endpoint(13 Weeks)
Mean Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) Medical Component Summary (MCS), Physical Component Summary (PCS), and Domain Scores(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference(Baseline and 13 Weeks)
Adverse Events Reported as Reason for Discontinuation(over 13 weeks)
Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes(Baseline and 13 Weeks)
Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride(Baseline and 13 Week Endpoint)
Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight(Baseline and 13 Weeks)
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders(Baseline and 13 Weeks)
Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint(13 Weeks)
Adverse Events Reported as Reason for Discontinuation in Nonresponders(over 13 Weeks)