Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain

Osteoarthritis Knee Pain Clinical Trial

Official title:

Protocol F1J-MC-HMFG 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: NCT00433290
• Other study ID #: 11198
• Secondary ID: F1J-MC-HMFG
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2007
• Last updated: August 26, 2009
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: August 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: 256
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• 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:

• 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.

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
duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
• Placebo
placebo every day (QD), by mouth (PO) for 13 weeks

Locations

Country	Name	City	State
Greece	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.	Athens
Greece	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.	Heraklion
Russian Federation	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.	Moscow
Sweden	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.	Gothenburg
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Greece,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Pain Inventory (BPI) 24-hour Average Rating		Baseline, Week 4, Week 7, Week 13	No
Secondary	Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)		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 Universities Osteoarthritis Index (WOMAC) Pain Subscale		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)		Baseline and 13 Weeks	No
Secondary	Number of Participants Who Responded to Treatment at 13 Week Endpoint		13 Weeks	No
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		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life		Baseline and 13 Weeks	No
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference		Baseline and 13 Weeks	No
Secondary	Adverse Events Reported as Reason for Discontinuation		over 13 weeks	Yes
Secondary	Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes		Baseline and 13 Weeks	Yes
Secondary	Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride		Baseline and 13 Week Endpoint	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Vital Signs - Weight		Baseline and 13 Weeks	Yes
Secondary	Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders		Baseline and 13 Weeks	No
Secondary	Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint		13 Weeks	No
Secondary	Adverse Events Reported as Reason for Discontinuation in Nonresponders		over 13 Weeks	Yes

External Links

•   Lilly Clinical Trial Registry