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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Brief Pain Inventory (BPI) 24-hour average rating [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Global Impression of Improvement (PGI-I) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Western Ontario and McMaster Osteoarthritis Index (WOMAC) physical function, pain and stiffness subscale [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Weekly mean of the 24-hour average pain and worst pain score [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity (CGI-S) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Response to treatment, as defined by a ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings computed from diary [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Medical Outcomes Study Short Form-36 (SF-36) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
EuroQoL Questionnaire - 5 Dimension [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Beck Depression Inventory - II (BDI-II) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale - anxiety subscale (HADS-A) [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Treatment-emergent adverse events [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Laboratory assessments [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]
Brief Pain Inventory (BPI)- Severity and Interference [ Time Frame: over 13 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI)- Severity and Interference [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
Response to treatment as defined by a ≥ 30% reduction of weekly mean in 24-hour average pain severity ratings computed from diary [ Time Frame: 7-13 weeks ] [ Designated as safety issue: No ]
Adverse events reported as reasons for discontinuations [ Time Frame: over 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	255
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 QD, 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 QD, 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

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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11198, F1J-MC-HMFG
Study First Received:	February 7, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00433290
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Osteoarthritis, Knee
Dopamine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009