Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433290
First Posted: February 9, 2007
Last Update Posted: September 2, 2009
Information provided by:
Eli Lilly and Company
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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:
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 ]
Secondary Outcome Measures:
- Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) [ Time Frame: 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale [ Time Frame: Baseline and 13 Weeks ]
- 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 ]
- Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 13 Weeks ]
- Number of Participants Who Responded to Treatment at 13 Week Endpoint [ Time Frame: 13 Weeks ]
- 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 ]
- Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference [ Time Frame: Baseline and 13 Weeks ]
- Adverse Events Reported as Reason for Discontinuation [ Time Frame: over 13 weeks ]
- Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes [ Time Frame: Baseline and 13 Weeks ]
- Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride [ Time Frame: Baseline and 13 Week Endpoint ]
- Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Vital Signs - Weight [ Time Frame: Baseline and 13 Weeks ]
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders [ Time Frame: Baseline and 13 Weeks ]
- Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint [ Time Frame: 13 Weeks ]
- Adverse Events Reported as Reason for Discontinuation in Nonresponders [ Time Frame: over 13 Weeks ]
| 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 |
|---|---|
| Experimental: A |
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
Other Names:
|
| Placebo Comparator: B |
Drug: Placebo
placebo every day (QD), by mouth (PO) for 13 weeks
|
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00433290 History of Changes |
| Other Study ID Numbers: |
11198 F1J-MC-HMFG |
| First Submitted: | February 7, 2007 |
| First Posted: | February 9, 2007 |
| Results First Submitted: | April 30, 2009 |
| Results First Posted: | August 24, 2009 |
| Last Update Posted: | September 2, 2009 |
| Last Verified: | August 2009 |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |