Clinical trial NCT00433290: Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
Official title: Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis Knee Pain
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-02-09
Enrollment: 256
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Brief Pain Inventory (BPI) 24-hour Average Rating
timeFrame: Baseline, Week 4, Week 7, Week 13
Secondary outcomes:
measure: Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)
timeFrame: 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline and 13 Weeks
measure: Number of Participants Who Responded to Treatment at 13 Week Endpoint
timeFrame: 13 Weeks
measure: 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
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
timeFrame: Baseline and 13 Weeks
measure: Adverse Events Reported as Reason for Discontinuation
timeFrame: over 13 weeks
measure: Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
timeFrame: Baseline and 13 Weeks
measure: Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
timeFrame: Baseline and 13 Week Endpoint
measure: Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
timeFrame: Baseline and 13 Weeks
measure: Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
timeFrame: Baseline and 13 Weeks
measure: Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint
timeFrame: 13 Weeks
measure: Adverse Events Reported as Reason for Discontinuation in Nonresponders
timeFrame: over 13 Weeks
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Edison
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New Jersey
city: Lake Jackson
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Texas
city: Athens
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Heraklion
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gothenburg
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.
citation: Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.
citation: Hochberg MC, Wohlreich M, Gaynor P, Hanna S, Risser R. Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis. J Rheumatol. 2012 Feb;39(2):352-8. doi: 10.3899/jrheum.110307. Epub 2011 Dec 1.