To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
39
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
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.
Time frame: Baseline, 4 weeks
Pharmacokinetics (PK) of LY2828360: Maximal Concentration (Cmax)
Time frame: 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.
Time frame: 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.
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline up to 15 weeks