Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I4F-EW-CCAC | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2828360 then Placebo | Experimental | 80 milligrams (mg) of LY2828360 daily by mouth for 4 weeks: placebo daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. |
|
| Placebo then LY2828360 | Experimental | Placebo daily by mouth for 4 weeks: LY2828360 daily by mouth for 4 weeks. There is a washout period of 3 weeks between treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2828360 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS) | The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon. | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax) | Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period) | |
| Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC) | AUC from time zero to 8 hours (AUC0-8h) is reported for this outcome measure. |
Not provided
Inclusion Criteria:
Are male or female participants with osteoarthritis (OA), as determined by medical history and physical examination. Males and females with stable medical problems that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.
Body weight greater than 40 kilograms (kg) and less than 120 kilograms (kg) with a body mass index (BMI) between 19-35 kilograms per square meter (kg/m^2) inclusive
Participant with osteoarthritic knee based on disease diagnostic criteria as presented in the Inclusion Disease Criteria, below
Blood pressure and pulse rate in supine and standing positions, within normal reference ranges for the population and investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have clinical laboratory test results within normal reference range for the population or investigator clinical research unit (CRU), or results with acceptable deviations that are judged to be not clinically significant by the investigator
Have venous access sufficient to allow for blood sampling
Have agreed to maintain the same activity level throughout the course of the study
Inclusion Disease Criteria:
Have a unilateral or bilateral osteoarthritis (OA) of the knee diagnosed according to the American College of Rheumatology (ACR) criteria. The clinical diagnosis of osteoarthritis (OA) will be confirmed by the American College of Rheumatology (ACR) clinical and radiographic criteria for classification of idiopathic osteoarthritis (OA) of the knee based upon the following criteria:
Have a Kellgren and Lawrence grade of I, II, III or IV
Have a mean score of at least 4 (moderate) and less than or equal to 8 (moderate-severe) on the 24-hour average pain score (0-10) (question 1) in the participant e-diary from screening to randomization for the knee joint during walking
Discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics/Non-Steroidal Anti-Inflammatory Drug [NSAID]) at least 2 weeks prior to randomization (participants are allowed limited use of analgesic medications)
Exclusion Criteria:
Exclusion Disease Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aalborg | Denmark |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 80 mg LY2828360 First, Then Placebo | Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks, followed by a 3-week washout period, then placebo once daily by mouth for 4 weeks. |
| FG001 | Placebo First, Then 80 mg LY2828360 | Participants received placebo once daily by mouth for 4 weeks, followed by a 3-week washout period, then 80 mg of LY2828360 once daily by mouth for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Period (4 Weeks) |
|
| |||||||||||||||||||||
| Washout Period (3 Weeks) |
| ||||||||||||||||||||||
| Second Treatment Period (4 Weeks) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 80 mg LY2828360 First, Then Placebo | Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks, followed by a 3-week washout period, then placebo once daily by mouth for 4 weeks. |
| BG001 | Placebo First, Then 80 mg LY2828360 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 From Baseline to 4 Week Endpoint in Weekly Mean of Daily 24-Hour Average Pain Scores (APS) | The weekly mean of the 24-Hour APS was calculated from participants' daily entries for 24-hour average pain rating on an 11-point scale with scores from 0 (no pain) to 10 (worst possible pain). Data were recorded twice a day at approximately the same time each day, preferably first thing in the morning and in the afternoon. | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 post-baseline weekly mean 24-Hour Average Pain value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 80 mg LY2828360 | Participants received 80 milligrams (mg) of LY2828360 once daily by mouth for 4 weeks. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717387 | CB2 receptor agonist LY2828360 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Administered orally |
|
| Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period) |
| Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores | The pain severity for night pain and worst pain was measured by an 11-point Likert scale, an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was used for assessment of night pain and worst pain each day, and evaluated as weekly means. Participants were asked to complete the severity pain for worst pain twice a day (in the morning and in the afternoon). The pain severity for night pain was filled out only once in the morning. | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI) | The CPSI is a validated 5-item questionnaire in which the following factors were assessed: trouble falling asleep due to pain (CPSI1), the need for sleep medication (CPSI2), awakenings by pain during the night (CPSI3) awakenings by pain in the morning (CPSI4), and overall sleep quality (CSPI5). All CPSI items are scored using a 100-millimeter (mm) visual analog scale (VAS) (VAS; 0=never and 100=always for CPSI1 through CPSI4, and 0=very poor and 100=excellent for CPSI5). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a self-rated questionnaire that assesses the participant's sleep habits during the last month and consists of 19 questions that cover 7 components (sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, sleeping medication use, and daytime dysfunction). Each item has a range of 0 (no difficulty) to 3 (severe difficulty). The 7 component scores were added to yield a global score with a range of 0 (no difficulty) to 21 (severe difficulties in all areas). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) | The BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. BPI-S consists of 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and pain right now. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The BPI-I average interference is the average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference scores range: 0 (does not interfere) to 10 (completely interferes). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Investigator Global Assessment of Changes (IGAC) | The IGAC is an investigator-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence the participant and his/her life, how do you then evaluate the participant's condition today (0=very good and 100=very bad). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Patient Global Assessment of Changes (PGAC) | The PGAC is a self-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence you and your life how do you then evaluate your condition over the last week (0=very good and 100=very bad). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Western Ontario and MacMaster (WOMAC) | WOMAC index completed by participant; consists of 24 questions, each based on 5-point Likert scale (0=none to 4=extreme). Has 3 subscales: pain, stiffness, and physical function. Pain subscale has 5 questions on pain associated with everyday tasks; subscale score ranges from 0=none to 20=extreme. Physical function subscale has 17 questions on physical function difficulties with everyday tasks; subscale score ranges from 0=none to 68=extreme. Stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in day); subscale score ranges from 0=none to 8=extreme. | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in Pain From 40 Meter Self-Paced Walk Test | The 40 meter self-paced walk test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after walking 40 meters. Scores range from 0 (no pain) to 100 (worst pain). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in the 11 Step Stair Climb Test | The 11 step stair climb test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after climbing 11 stairs. Scores range from 0 (no pain) to 100 (worst pain). | Baseline, 4 weeks |
| Change From Baseline to 4 Week Endpoint in DoloTest Sum Score | The DoloTest® is a self-reported assessment composed of 8 visual analog scale (VAS) items ranging from 0 (none) to 100 (worst possible) for the following domains: pain, problems with light physical activities, problems with more strenuous physical activities, problems doing your job, reduced energy and strength, low spirit, reduced social life, and problems sleeping). The scale is arranged in a radar plot to provide a graphic presentation of the test result. The DoloTest® Sum Score is equal to the sum of each scored domain; scores range from 0 (none) to 800 (worst possible). | Baseline, 4 weeks |
| Number of Participants With Treatment-Emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. | Baseline up to 15 weeks |
| Protocol Violation |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
Participants received placebo once daily by mouth for 4 weeks, followed by a 3-week washout period, then 80 mg of LY2828360 once daily by mouth for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 |
| Placebo |
Participants received placebo once daily by mouth for 4 weeks. |
|
|
| Secondary | Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax) | The analysis included all randomized participants receiving at least 1 dose of LY2828360 with interpretable PK data. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period) |
|
|
|
| Secondary | Pharmacokinetics (PK) of LY2828360: Area Under the Concentration-Time Curve (AUC) | AUC from time zero to 8 hours (AUC0-8h) is reported for this outcome measure. | The analysis included all randomized participants receiving at least 1 dose of LY2828360 with interpretable PK data. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/mL) | Pre-last dose to 8 hours post-last dose (at end of each 4-week treatment period) |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Weekly Mean of Night Pain and Worst Daily Pain Scores | The pain severity for night pain and worst pain was measured by an 11-point Likert scale, an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was used for assessment of night pain and worst pain each day, and evaluated as weekly means. Participants were asked to complete the severity pain for worst pain twice a day (in the morning and in the afternoon). The pain severity for night pain was filled out only once in the morning. | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline night/worst pain value and at least 1 post-baseline weekly mean night/worst pain value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Chronic Pain Sleep Inventory (CPSI) | The CPSI is a validated 5-item questionnaire in which the following factors were assessed: trouble falling asleep due to pain (CPSI1), the need for sleep medication (CPSI2), awakenings by pain during the night (CPSI3) awakenings by pain in the morning (CPSI4), and overall sleep quality (CSPI5). All CPSI items are scored using a 100-millimeter (mm) visual analog scale (VAS) (VAS; 0=never and 100=always for CPSI1 through CPSI4, and 0=very poor and 100=excellent for CPSI5). | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 postbaseline CPSI value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a self-rated questionnaire that assesses the participant's sleep habits during the last month and consists of 19 questions that cover 7 components (sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, sleeping medication use, and daytime dysfunction). Each item has a range of 0 (no difficulty) to 3 (severe difficulty). The 7 component scores were added to yield a global score with a range of 0 (no difficulty) to 21 (severe difficulties in all areas). | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 postbaseline PSQI value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) | The BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. BPI-S consists of 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and pain right now. Severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The BPI-I average interference is the average of 7 questions assessing interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference scores range: 0 (does not interfere) to 10 (completely interferes). | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with baseline and at least 1 postbaseline BPI-S/BPI-I value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Investigator Global Assessment of Changes (IGAC) | The IGAC is an investigator-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence the participant and his/her life, how do you then evaluate the participant's condition today (0=very good and 100=very bad). | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with baseline and at least 1 postbaseline IGAC value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Patient Global Assessment of Changes (PGAC) | The PGAC is a self-reported subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to answer the following question: If you take into consideration all the various ways the knee pain influence you and your life how do you then evaluate your condition over the last week (0=very good and 100=very bad). | The analysis included all randomized participants who received at least 1 dose of the investigational product and with a baseline and at least 1 postbaseline PGAC value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Western Ontario and MacMaster (WOMAC) | WOMAC index completed by participant; consists of 24 questions, each based on 5-point Likert scale (0=none to 4=extreme). Has 3 subscales: pain, stiffness, and physical function. Pain subscale has 5 questions on pain associated with everyday tasks; subscale score ranges from 0=none to 20=extreme. Physical function subscale has 17 questions on physical function difficulties with everyday tasks; subscale score ranges from 0=none to 68=extreme. Stiffness subscale has 2 questions on stiffness associated with time of day (morning versus later in day); subscale score ranges from 0=none to 8=extreme. | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 postbaseline WOMAC value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in Pain From 40 Meter Self-Paced Walk Test | The 40 meter self-paced walk test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after walking 40 meters. Scores range from 0 (no pain) to 100 (worst pain). | The analysis included all randomized participants receiving at least 1 dose of the investigational product and with a baseline and at least 1 postbaseline 40 Meter Self-Paced Walk test value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in the 11 Step Stair Climb Test | The 11 step stair climb test is a participant-rated subjective evaluation using a 100 millimeter (mm) visual analog scale (VAS) to assess pain after climbing 11 stairs. Scores range from 0 (no pain) to 100 (worst pain). | The analysis included all randomized participants receiving at least 1 dose of investigational product and with baseline and at least 1 postbaseline 11 Step Stair Climb Test value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Change From Baseline to 4 Week Endpoint in DoloTest Sum Score | The DoloTest® is a self-reported assessment composed of 8 visual analog scale (VAS) items ranging from 0 (none) to 100 (worst possible) for the following domains: pain, problems with light physical activities, problems with more strenuous physical activities, problems doing your job, reduced energy and strength, low spirit, reduced social life, and problems sleeping). The scale is arranged in a radar plot to provide a graphic presentation of the test result. The DoloTest® Sum Score is equal to the sum of each scored domain; scores range from 0 (none) to 800 (worst possible). | The analysis included all randomized participants receiving at least 1 dose of investigational product and with a baseline and at least 1 postbaseline DoloTest value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. | The C-SSRS analysis included all randomized participants. | Posted | Count of Participants | Participants | No | Baseline up to 15 weeks |
|
|
|
| 0 |
| 37 |
| 14 |
| 37 |
| EG001 | Placebo | Participants received placebo once daily by mouth for 4 weeks. | 0 | 36 | 16 | 36 |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
Not provided
| CPSI3: Awakenings by pain during the night |
|
| CPSI4: Awakenings by pain in the morning |
|
| CPSI5: Overall sleep quality |
|
| BPI-S Average Pain in the Past 24 Hours |
|
| BPI-S Pain Right Now |
|
| BPI-I Average Interference |
|
| WOMAC: Physical Function |
|