Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433290
First received: February 7, 2007
Last updated: August 26, 2009
Last verified: August 2009
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 |
|---|---|
| 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| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433290
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:
No publications provided by Eli Lilly and Company
Additional 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 |
| Study First Received: | February 7, 2007 |
| Results First Received: | April 30, 2009 |
| Last Updated: | August 26, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Duloxetine Adrenergic Agents Adrenergic Uptake Inhibitors Analgesics Antidepressive Agents Central Nervous System Agents Dopamine Agents |
Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sensory System Agents Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015