Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00433290

Purpose

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

Condition	Intervention	Phase
Osteoarthritis Knee Pain	Drug: Duloxetine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change in Brief Pain Inventory (BPI) 24-hour Average Rating [ Time Frame: Baseline, Week 4, Week 7, Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	256
Study Start Date:	February 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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
B: Placebo Comparator	Drug: Placebo placebo every day (QD), by mouth (PO) for 13 weeks

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433290

Locations

United States, Florida
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, 33916
United States, New Jersey
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, 08817
United States, Texas
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, 77566
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, 14561
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, Greece, 71110
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, Russian Federation, 119992
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, Sweden, 40014

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11198, F1J-MC-HMFG
Study First Received:	February 7, 2007
Results First Received:	April 30, 2009
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00433290 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Osteoarthritis
Joint Diseases
Psychotropic Drugs
Pain
Rheumatic Diseases
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Osteoarthritis, Knee
Dopamine
Musculoskeletal Diseases
Arthritis
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Rheumatic Diseases

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Osteoarthritis, Knee
Serotonin Agents
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 02, 2009