Phase 3 N=256 Randomized Quadruple-blind Treatment

Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Osteoarthritis Knee Pain

Bottom Line

View on ClinicalTrials.gov: NCT00433290 ↗

Enrolled (actual)

256

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Change in Brief Pain Inventory (BPI) 24-hour Average Rating — -1.80; -1.12; -2.47; -1.41 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Duloxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Brief Pain Inventory (BPI) 24-hour Average Rating	-1.80; -1.12; -2.47; -1.41; -2.72; -1.88	<0.001 sig
SECONDARY Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)	2.85; 3.09	0.164
SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale	35.05; 36.82; -13.78; -10.75	0.016 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale	10.24; 10.35; -4.27; -3.49	0.068
SECONDARY Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale	4.27; 4.50; -1.63; -1.36	0.064
SECONDARY Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores	6.05; 6.08; -2.39; -1.78; 7.58; 7.53	0.008 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)	-0.63; -0.32	0.009 sig
SECONDARY Number of Participants Who Responded to Treatment at 13 Week Endpoint	79; 56	<0.001 sig
SECONDARY 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	55.86; 54.47; 0.35; 1.10; 30.59; 28.70	0.897
SECONDARY Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)	0.68; 0.66; 0.09; 0.08	0.209
SECONDARY Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)	4.29; 5.35; -0.82; -1.25	0.871
SECONDARY Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)	4.26; 4.16; -1.11; -0.69	0.138
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score	7.49; 7.50; -2.74; -1.94	0.003 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score	4.70; 4.63; -1.95; -1.24	0.015 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score	6.09; 6.16; -2.54; -1.78	<0.001 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score	5.45; 5.36; -2.57; -1.80	0.007 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity	4.70; 5.17; -2.26; -1.92	0.050
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood	3.35; 3.60; -1.59; -1.72	0.913
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability	5.41; 5.54; -2.63; -2.07	0.066
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work	4.77; 4.88; -2.43; -1.56	0.001 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People	2.36; 2.37; -1.16; -0.89	0.260
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep	3.66; 4.02; -1.91; -1.91	0.489
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life	3.10; 3.29; -1.53; -1.23	0.131
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference	3.91; 4.13; -1.93; -1.62	0.082
SECONDARY Adverse Events Reported as Reason for Discontinuation	5; 0; 1; 2; 2; 0	—
SECONDARY Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes	77.33; 75.90; 2.38; -3.43; 22.61; 24.23	<0.001 sig
SECONDARY Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride	104.38; 104.18; -0.83; -0.08	0.042 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate	68.74; 69.73; 2.55; 0.06	0.005 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure	132.20; 131.42; -1.03; 0.89; 79.73; 79.83	0.285
SECONDARY Change From Baseline to 13 Week Endpoint in Vital Signs - Weight	81.01; 80.49; -0.65; 0.47	<0.001 sig
SECONDARY Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders	5.30; -0.76	0.040 sig
SECONDARY Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint	9	—
SECONDARY Adverse Events Reported as Reason for Discontinuation in Nonresponders	1; 1; 1	—

Summary

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00433290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.