Osteoarthritis Knee PainPhase 3NCT00408421
Duloxetine Versus Placebo for Osteoarthritis Knee Pain
A Phase 3 study testing Duloxetine in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 27 sites in 3 countries.
Trial summary
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis Knee Pain
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 27 sitesin 3 countries
- Study dates
- Nov 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients with osteoarthritis knee pain.
Who cannot join
- 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.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
- Daily use of narcotics.
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
United States21 sites
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.
Beverly Hills, California, 90211
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.
Billerica, Massachusetts, 01821
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Chandler, Arizona, 85225
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Chicago, Illinois, 60611
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DeLand, Florida, 32720
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Edison, New Jersey, 08817
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Fort Myers, Florida, 33916
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Lake Jackson, Texas, 77566
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Morton Grove, Illinois, 60053
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Northridge, California, 91325
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Reno, Nevada, 89502
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South Miami, Florida, 33143
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Stratford, New Jersey, 08084
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Stuart, Florida, 34996
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Toms River, New Jersey, 08755
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Tulsa, Oklahoma, 74135
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Waco, Texas, 76708
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Walnut Creek, California, 94598
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Waltham, Massachusetts, 02453
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Westborough, Massachusetts, 01581
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Wichita Falls, Texas, 76309
Romania4 sites
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Brasov, 500365
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Bucharest, 70266
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Cluj-Napoca, 400132
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Iași, 700656
Puerto Rico2 sites
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.
Hato Rey, 00917
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.
San Juan, 00935
About this study
Official title: 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.
- Conditions
- Osteoarthritis Knee Pain
- Being tested
- Duloxetine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called LY248686, Cymbalta
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | duloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks Receives: Drug: Duloxetine |
| B | Placebo comparator | placebo daily (QD), by mouth (PO) for 13 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).
Measured: Over 13 Weeks
Secondary outcomes (34)
Patient Global Impression of Improvement at 13 Week Endpoint
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
The WOMAC index (pain, stiffness, physical function subscales) will be completed by the patient. The index has 24 questions. Each question is answered using a 5-point Likert scale (0 to 4). The Total score has a range from 0 (none) to 96 (extreme).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Measured: Baseline and 13 Weeks
Weekly Change From Baseline in the 24-Hour Worst Pain Score
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The value is the change from baseline in the weekly mean of the 24-hour worst pain score on the scale.
Measured: Over 13 Weeks
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). This value is the change from baseline in the weekly mean of the 24-hour average pain score on the scale.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity
A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life
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).
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference
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).
Measured: Baseline and 13 Weeks
Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings
Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain).
Measured: Over 13 Weeks
Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase
Number of participants who experienced a response to treatment, which was defined as having a >=30% reduction of the weekly mean in 24-hour average pain severity ratings. Response to treatment over the last 6 weeks of the trial (after patients were re-randomized) were compared to baseline measures.
Measured: Over 13 Weeks
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) has been constructed based on the 8 SF-36 domains.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
A self-reported questionnaire that consists of 36 questions covering 8 health domains. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score
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.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score
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.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Measured: Baseline and 13 Weeks
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase
Change from baseline to endpoint in alkaline phosphatase using central laboratory reference ranges.
Measured: Baseline and 13 Weeks
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid
Change from baseline to endpoint in uric acid using central laboratory reference ranges.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate
Pulse rate (heart rate) measured in the sitting position.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic
Diastolic blood pressure measured in the sitting position.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic
Systolic blood pressure measured in the sitting position.
Measured: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Measured: Baseline and 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Knee PainStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408421
- Sponsor's protocol ID
- 10546
- Other IDs
- F1J-MC-HMEP
- Status last verified
- Jul 2009
- First submitted
- 6 Dec 2006
- Last updated
- 19 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31505082Williamson 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.
PubMed 24650448Hochberg 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.
PubMed 22133624
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine 60 to 120 mg Versus Placebo in the Treatment of Patients With Osteoarthritis Knee Pain
- ClinicalTrials.gov ID
- NCT00408421
- Acronym / sponsor ID
- 10546
- Conditions
- Osteoarthritis Knee Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 7 Dec 2006 (estimated)
- Results
- Posted 19 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Duloxetineduloxetine 30 mg, daily (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 6 weeks then duloxetine 60 mg or 120 mg QD, PO for 6 weeks |
| B | Placebo comparator | Drug: placeboplacebo daily (QD), by mouth (PO) for 13 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female outpatients with osteoarthritis knee pain.
Key exclusion criteria (6 listed)
- 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.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: LY248686, Cymbalta | Drug | A |
| placebo | Drug | B |
Primary outcome
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary
Time frame: Over 13 Weeks
This is an ordinal scale assessing the 24-hour average pain with scores from 0 (no pain) to 10 (worst possible pain).
34 secondary outcomes
Patient Global Impression of Improvement at 13 Week Endpoint
Time frame: 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
Time frame: Baseline and 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 Osteoarthritis Index (WOMAC) - Total Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Worst Pain Score
Time frame: Baseline and 13 Weeks
Weekly Change From Baseline in the 24-Hour Worst Pain Score
Time frame: Over 13 Weeks
Change From Baseline to 13 Week Endpoint in Weekly Mean of 24-Hour Average Pain in the Re-Randomized Treatment Phase
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) - Worst Pain Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Least Pain Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Pain Right Now Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - General Activity
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Mood
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Walking Ability
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Normal Work
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Relations With Other People
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Sleep
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference Score - Enjoyment of Life
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Average Interference
Time frame: Baseline and 13 Weeks
Response to Treatment - The Number of Participants With a >= 30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings
Time frame: Over 13 Weeks
Response to Treatment - The Number of Participants With a >=30% Reduction of Weekly Mean in 24-Hour Average Pain Severity Ratings in the Re-Randomized Treatment Phase
Time frame: Over 13 Weeks
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Mental Health Component Summary
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Euro-Quality of Life - 5 Dimensions (EQ-5D): US Based Index Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Beck Depression Inventory-II - Total Score
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
Time frame: Baseline and 13 Weeks
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Alkaline Phosphatase
Time frame: Baseline and 13 Weeks
Statistically Significant Change From Baseline to 13 Week Endpoint in Laboratory Data - Chemistry Analytes: Uric Acid
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Pulse Rate
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Diastolic
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure (BP) Systolic
Time frame: Baseline and 13 Weeks
Change From Baseline to 13 Week Endpoint in Vital Signs - Weight
Time frame: Baseline and 13 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31505082Yue 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.
- Derived from this study: PubMed 24650448Williamson 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.
- Derived from this study: PubMed 22133624Hochberg 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.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Osteoarthritis Knee Pain, run by Eli Lilly and Company at 27 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Romania, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Change From Baseline in the 24-Hour Average Pain Rating Using an 11-Point Numerical Likert Scale Patient Diary (time frame: Over 13 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00408421, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009.