Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
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| ClinicalTrials.gov Identifier: NCT00433290 |
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Recruitment Status :
Completed
First Posted : February 9, 2007
Results First Posted : August 24, 2009
Last Update Posted : September 2, 2009
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Brief Summary:
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis Knee Pain | Drug: Duloxetine Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 256 participants |
| 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 |
| Study Start Date : | February 2007 |
| Actual Primary Completion Date : | May 2008 |
| Actual Study Completion Date : | May 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
| 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:
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| Placebo Comparator: B |
Drug: Placebo
placebo every day (QD), by mouth (PO) for 13 weeks |
Primary Outcome Measures :
- Change in Brief Pain Inventory (BPI) 24-hour Average Rating [ Time Frame: Baseline, Week 4, Week 7, Week 13 ]A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Changes are timepoint minus baseline.
Secondary Outcome Measures :
- Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) [ Time Frame: 13 Weeks ]A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale [ Time Frame: Baseline and 13 Weeks ]The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The physical function subscale has 17 questions on physical function difficulties with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The physical function subscale has a range of scores of 0 (none) to 68 (extreme).
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale [ Time Frame: Baseline and 13 Weeks ]The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The pain subscale has 5 questions on pain associated with every day tasks. Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme).
- Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale [ Time Frame: Baseline and 13 Weeks ]The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in the day). Each question is answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 8 (extreme).
- 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 ]This assesses the weekly mean of the average pain and worst pain experienced over the last 24-hours. This is an ordinal scale with scores for each subscale (average pain and worst pain) ranging from 0 (no pain) to 10 (worst possible pain). Change = endpoint minus baseline.
- Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 13 Weeks ]Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
- Number of Participants Who Responded to Treatment at 13 Week Endpoint [ Time Frame: 13 Weeks ]Response to treatment was defined as a ≥ 30% reduction from baseline to endpoint in Brief Pain Inventory (BPI) average pain score. The BPI measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- 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 ]MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores:general health=5-25, physical functioning=10-30, Role-physical=4-8, Role-emotional=3-6, social functioning=2-10, bodily pain=2-11, vitality=4-24, mental health=5-30.
- Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) [ Time Frame: Baseline and 13 Weeks ]The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
- Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) [ Time Frame: Baseline and 13 Weeks ]A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
- Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [ Time Frame: Baseline and 13 Weeks ]A 14-item questionnaire with 2 subscales: anxiety (7 items) and depression (7 items). Each item is rated on a 4-point scale (0 to 3), giving maximum scores of 21 for anxiety subscale. Scores of 11 or more are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours for general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference [ Time Frame: Baseline and 13 Weeks ]A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).
- 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 ]
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Non-Responders were defined as patients with a <30% reduction from baseline to visit 4 (7 weeks) in Brief Pain Inventory (BPI) average pain score.
- Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint [ Time Frame: 13 Weeks ]Response was defined as a >=30% reduction from baseline to endpoint in Brief Pain Inventory average pain score. Nonresponders were defined as participants with a <30% reduction from baseline to Visit 4 (7 Weeks) in Brief Pain Inventory average pain score.
- Adverse Events Reported as Reason for Discontinuation in Nonresponders [ Time Frame: over 13 Weeks ]Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score.
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| 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.
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00433290 |
| Other Study ID Numbers: |
11198 F1J-MC-HMFG |
| First Posted: | February 9, 2007 Key Record Dates |
| Results First Posted: | August 24, 2009 |
| Last Update Posted: | September 2, 2009 |
| Last Verified: | August 2009 |
Additional relevant MeSH terms:
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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 |