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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMFG |
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The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with osteoarthritis knee pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory (BPI) 24-hour Average Rating | 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. | Baseline, Week 4, Week 7, Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) | 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). | 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Physical Function Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 | 33916 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31505082 | Derived | 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. | |
| 24650448 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | placebo every day (QD), by mouth (PO) for 13 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Brief Pain Inventory (BPI) 24-hour Average Rating | 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. | All randomized participants. Intent-to-treat analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 4, Week 7, Week 13 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Placebo | Drug | placebo every day (QD), by mouth (PO) for 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). |
| Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | 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. | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) | 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. | Baseline and 13 Weeks |
| Number of Participants Who Responded to Treatment at 13 Week Endpoint | 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). | 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 | 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. | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | 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. | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | 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. | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | 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.' | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | Baseline and 13 Weeks |
| Adverse Events Reported as Reason for Discontinuation | over 13 weeks |
| Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Baseline and 13 Weeks |
| Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Baseline and 13 Week Endpoint |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Baseline and 13 Weeks |
| Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders | 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 |
| Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint | 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. | 13 Weeks |
| Adverse Events Reported as Reason for Discontinuation in Nonresponders | Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score. | over 13 Weeks |
| United States |
| 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 | 08817 | United States |
| 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 | 77566 | United States |
| 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 | 14561 | 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. | Heraklion | 71110 | 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. | Moscow | 119992 | Russia |
| 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 | 40014 | Sweden |
| 22133624 | Derived | 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. |
| Withdrawal by Subject |
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| Protocol Violation |
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| Physician Decision |
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| Entry Criteria Not Met |
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| Lost to Follow-up |
|
placebo every day (QD), by mouth (PO) for 13 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nonsteroidal Anti-Inflammatory Drug (NSAID) Use | Number | participants |
|
| Race/Ethnicity | Number | participants |
|
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/meters squared |
|
| Body Weight | Mean | Standard Deviation | kilograms |
|
| Brief Pain Inventory Average Pain | 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). | Mean | Standard Deviation | units on a scale |
|
| Clinical Global Impressions of Severity Scale (CGI-S) | 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. | Mean | Standard Deviation | units on a scale |
|
| Duration of Osteoarthritis Pain Since Onset | Mean | Standard Deviation | years |
|
| Duration of Osteoarthritis Since Diagnosis | Mean | Standard Deviation | years |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weekly Mean of 24 Hour Average Pain Severity | This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represents the weekly mean of the scores of the average pain severity over the last 24 hours. | Mean | Standard Deviation | units on a scale |
|
placebo every day (QD), by mouth (PO) for 13 weeks |
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| Secondary | Mean Values at 13 Week Endpoint in Patient Global Impression of Improvement (PGI-I) | 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). | All randomized participants with at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | 13 Weeks |
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| Secondary | 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). | All randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
|
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| Secondary | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities 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). | All randomized participants with baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Western Ontario and McMaster Universities 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). | All randomized participants with baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Weekly Mean of the 24-Hour Average Pain and Worst Pain Scores | 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. | All randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Clinical Global Impression of Severity (CGI-S) | 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. | All randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Number of Participants Who Responded to Treatment at 13 Week Endpoint | 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). | Number of randomized participants with non-missing response values. | Posted | Number | participants | 13 Weeks |
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| Secondary | 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 | 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. | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D) | 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. | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Beck Depression Inventory - II (BDI-II) | 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. | All randomized participants. Intent-to-treat analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) | 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.' | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Severity: 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). | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Severity: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: General Activity | 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory Interference: 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). | The number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Adverse Events Reported as Reason for Discontinuation | All randomized participants. | Posted | Number | participants | over 13 weeks |
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| Secondary | Statisically Significant Change From Baseline to 13 Week Endpoint in Laboratory Analytes | Number of participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | Units/Liter | Baseline and 13 Weeks |
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| Secondary | Statisically Significant Change From Baseline to 13 Week Endpoint in Chloride | Number of randomized participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | millimole per Liter | Baseline and 13 Week Endpoint |
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| Secondary | Change From Baseline to 13 Week Endpoint in Vital Signs - Heart Rate | Number of participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | beats per minute | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Vital Signs - Blood Pressure | Number of participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Vital Signs - Weight | Number of participants with a baseline and at least one non-missing post-baseline value. | Posted | Mean | Standard Deviation | kilograms | Baseline and 13 Weeks |
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| Secondary | Change From Baseline to 13 Week Endpoint in Brief Pain Inventory - Average Pain Score in Nonresponders | 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 participants who did not respond to treatment after 6 weeks of treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 13 Weeks |
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| Secondary | Number of Nonresponders at Week 7 Who Responded at Week 13 Endpoint | 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. | Number of randomized participants who were non-responders at Visit 4 (7 weeks) and with non-missing response values. | Posted | Number | participants | 13 Weeks |
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| Secondary | Adverse Events Reported as Reason for Discontinuation in Nonresponders | Nonresponders were defined as participants with a <30% reduction from baseline to Visit 7 (7 weeks) in Brief Pain Inventory average pain score. | Number of randomized participants who were nonresponders at Visit 4 (7 weeks). | Posted | Number | participants | over 13 Weeks |
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| 3 |
| 64 |
| EG001 | Placebo | placebo every day (QD), by mouth (PO) for 13 weeks | 2 | 41 |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Drug intolerance | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Ejaculation disorder | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |
| Baseline Weekly 24-Hour Worst Pain |
|
| Change in Weekly 24-Hour Worst Pain |
|
| ANCOVA |
Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-value. |
| 0.047 |
P-value for Change in Weekly 24-Hour Worst Pain. Change = Endpoint minus baseline. |
| 95 |
| No |
| Superiority or Other |
| Physical Component Summary Baseline (n=119, n=121) |
|
| Physical Component Summary Change from Baseline |
|
| Bodily Pain Baseline (n=121, n=124) |
|
| Bodily Pain Change from Baseline |
|
| General Health Baseline (n=120, n=122) |
|
| General Health Change from Baseline |
|
| Mental Health Baseline (n=121, n=124) |
|
| Mental Health Change from Baseline |
|
| Physical Functioning Baseline (n=120, n=125) |
|
| Physical Functioning Change from Baseline |
|
| Role-Emotional Baseline (n=121, n=125) |
|
| Role-Emotional Change from Baseline |
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| Role-Physical Baseline (n=121, n=125) |
|
| Role-Physical Change from Baseline |
|
| Social Functioning Baseline (n=121, n=125) |
|
| Social Functioning Change from Baseline |
|
| Vitality Baseline (n=121, n=124) |
|
| Vitality Change from Baseline |
|
| ANCOVA |
Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. |
| <0.001 |
P-value for Physical Component Summary Change from Baseline. Change = Endpoint minus baseline. |
| 95 |
| No |
| Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.004 | P-value for Bodily Pain Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.051 | P-value for General Health Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.508 | P-value for Mental Health Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.019 | P-value for Physical Functioning Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.415 | P-value for Role-Emotional Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.006 | P-value for Role-Physical Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.342 | P-value for Social Functioning Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| ANCOVA | Model: Change = Treatment, Pooled Investigator, NSAID use and Baseline for main effects p-values. | 0.135 | P-value for Vitality Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| Regression, Linear |
| 0.002 |
P-value for direct analgesic effect. The null hypothesis was tested by testing a1=0 versus a1≠0. |
| 95 |
| No |
| Superiority or Other |
| Arthralgia |
|
| Asthenia |
|
| Constipation |
|
| Abdominal pain upper |
|
| Abnormal dreams |
|
| Anxiety |
|
| Atrial fibrillation |
|
| Diarrhoea |
|
| Drug intolerance |
|
| Dyspepsia |
|
| Ejaculation disorder |
|
| Erectile dysfunction |
|
| Haemorrhoids |
|
| Hot flush |
|
| Lethargy |
|
| Memory impairment |
|
| Palpitations |
|
| Pyelonephritis acute |
|
| Sleep disorder |
|
| Supraventricular tachycardia |
|
| Aspartate Amino Transaminase (AST) Baseline |
|
| AST Change from Baseline (n=117,n=124) |
|
| Gammaglutamyl Transpeptidase (GGT) Baseline |
|
| GGT Change from Baseline (n=120,n=126) |
|
| 0.010 |
P-value for AST Change from Baseline. Change = Endpoint minus baseline. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | 0.023 | P-value for GGT Change from Baseline. Change = Endpoint minus baseline. | 95 | No | Superiority or Other |
| Diastolic Blood Pressure (DBP) Baseline |
|
| DBP Change from Baseline |
|
P-value for DBP Change from Baseline. Change = Endpoint minus baseline. |
| 95 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|
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