Duloxetine Versus Placebo for Osteoarthritis Knee Pain

Osteoarthritis Knee Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00408421
• Other study ID #: 10546
• Secondary ID: F1J-MC-HMEP
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2006
• Last updated: July 7, 2009
• Start date: November 2006
• Est. completion date: October 2007

Study information

• Verified date: July 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 40.

• Major depressive disorder.

• Daily use of narcotics.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee Pain
• Osteoarthritis, Knee

Intervention

Drug:
• Duloxetine

• placebo

Locations

Country	Name	City	State
Puerto Rico	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.	Hato Rey
Puerto Rico	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.	San Juan
Romania	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.	Brasov
Romania	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.	Bucharest
Romania	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.	Cluj-Napoca
Romania	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.	Iasi
United States	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.	Beverly Hills	California
United States	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.	Billerica	Massachusetts
United States	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.	Chandler	Arizona
United States	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.	Chicago	Illinois
United States	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.	Deland	Florida
United States	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.	Edison	New Jersey
United States	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.	Fort Myers	Florida
United States	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.	Lake Jackson	Texas
United States	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.	Morton Grove	Illinois
United States	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.	Northridge	California
United States	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.	Reno	Nevada
United States	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.	S. Miami	Florida
United States	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.	Stratford	New Jersey
United States	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.	Stuart	Florida
United States	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.	Toms River	New Jersey
United States	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.	Tulsa	Oklahoma
United States	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.	Waco	Texas
United States	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.	Walnut Creek	California
United States	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.	Waltham	Massachusetts
United States	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.	Westborough	Massachusetts
United States	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.	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary		Over 13 Weeks	No
Secondary	Patient Global Impression of Improvement at 13 Week Endpoint		13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score		Baseline and 13 Weeks	No
Secondary	Weekly Change From Baseline in the 24-Hour Worst Pain Score		Over 13 Weeks	No
Secondary	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	No
Secondary	Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference		Baseline and 13 Weeks	No
Secondary	Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings		Over 13 Weeks	No
Secondary	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	No
Secondary	Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale		Baseline and 13 Weeks	No
Secondary	Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase		Baseline and 13 Weeks	Yes
Secondary	Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Weight		Baseline and 13 Weeks	Yes

External Links

•   Lilly Clinical Trial Registry