- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00433290
Duloxetine vs. Placebo in the Treatment of Osteoarthritis Knee Pain
August 26, 2009 updated by: Eli Lilly and Company
Protocol F1J-MC-HMFG Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
256
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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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.
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Heraklion, Greece, 71110
- 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.
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Moscow, Russian Federation, 119992
- 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.
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Gothenburg, Sweden, 40014
- 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.
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Florida
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Fort Myers, Florida, United States, 33916
- 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.
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New Jersey
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Edison, New Jersey, United States, 08817
- 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.
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Texas
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Lake Jackson, Texas, United States, 77566
- 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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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
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placebo every day (QD), by mouth (PO) for 13 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Brief Pain Inventory (BPI) 24-hour Average Rating
Time Frame: Baseline, Week 4, Week 7, Week 13
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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.
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Baseline, Week 4, Week 7, Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Time Frame: Baseline and 13 Weeks
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Baseline and 13 Weeks
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Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I)
Time Frame: 13 Weeks
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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).
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13 Weeks
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Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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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
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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.
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S)
Time Frame: Baseline and 13 Weeks
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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.
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Baseline and 13 Weeks
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Number of Participants Who Responded to Treatment at 13 Week Endpoint
Time Frame: 13 Weeks
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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).
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13 Weeks
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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
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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.
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
Time Frame: Baseline and 13 Weeks
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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.
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II)
Time Frame: Baseline and 13 Weeks
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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.
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
Time Frame: Baseline and 13 Weeks
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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.'
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: Worst Pain Score
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Least Pain Score
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Average Pain Score
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: Pain Right Now Score
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Mood
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Walking Ability
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Normal Work
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Relations With Other People
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Sleep
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Enjoyment of Life
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: Average Interference
Time Frame: Baseline and 13 Weeks
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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).
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Baseline and 13 Weeks
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Adverse Events Reported as Reason for Discontinuation
Time Frame: over 13 weeks
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over 13 weeks
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Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes
Time Frame: Baseline and 13 Weeks
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Baseline and 13 Weeks
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Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride
Time Frame: Baseline and 13 Week Endpoint
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Baseline and 13 Week Endpoint
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Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate
Time Frame: Baseline and 13 Weeks
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure
Time Frame: Baseline and 13 Weeks
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Baseline and 13 Weeks
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Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders
Time Frame: Baseline and 13 Weeks
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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. |
Baseline and 13 Weeks
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Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint
Time Frame: 13 Weeks
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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.
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13 Weeks
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Adverse Events Reported as Reason for Discontinuation in Nonresponders
Time Frame: over 13 Weeks
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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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over 13 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.
- Yue L, Wang J, Enomoto H, Fujikoshi S, Alev L, Cheng YY, Skljarevski V. The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain? Pain Pract. 2020 Feb;20(2):129-137. doi: 10.1111/papr.12835. Epub 2019 Nov 20.
- Hochberg MC, Wohlreich M, Gaynor P, Hanna S, Risser R. Clinically relevant outcomes based on analysis of pooled data from 2 trials of duloxetine in patients with knee osteoarthritis. J Rheumatol. 2012 Feb;39(2):352-8. doi: 10.3899/jrheum.110307. Epub 2011 Dec 1.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 7, 2007
First Submitted That Met QC Criteria
February 7, 2007
First Posted (Estimate)
February 9, 2007
Study Record Updates
Last Update Posted (Estimate)
September 2, 2009
Last Update Submitted That Met QC Criteria
August 26, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- 11198 (DAIDS ES Registry Number)
- F1J-MC-HMFG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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