| Outcome Measures: |
Primary: Number of Participants Experiencing a Treatment Emergent Adverse Event (TEAE), A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state. Relationship of TEAEs to study drug is assessed by the investigator. Clinically significant changes from baseline in clinical laboratory evaluations, neurological examinations, and electrocardiograms are reported as TEAEs., Baseline up to 30 days after last dose, up to 25 months|Patients Answering Yes to Any Question on the Columbia-Suicide Severity Rating Scale (C-SSRS), The C-SSRS is described as a scale developed at Columbia University that has 2-6 questions each in categories of Suicidal Ideation, Intensity of Ideation, Suicidal Behavior, and Actual Attempts. Four constructs were measured. Severity of Suicidal ideation is rated on a 5-point ordinal scale. Intensity of ideation is comprised of 5 items (frequency, duration, controllability, deterrents, and reason for ideation), each rated on a 5-point ordinal scale. Suicidal behavior is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and non-suicidal self-injurious behavior. Lethality, assesses actual attempts; actual lethality is rated on a 6-point ordinal scale, and if actual lethality is 0, potential lethality of attempts is rated on a 3-point ordinal scale.The higher the C-SSRS score, the higher the suicide risk (ie. worse outcome)., Screening up to Week 13 postdose | Secondary: Mean Weekly Average of Individual Daily Pain Scores (ADPS), Each day participants will rate their worst pain over the last 24 hours on a scale from 0-10, where 0=no pain and 10=worst pain imaginable. Each week individual pain scores will be averaged, and the mean weekly score for the treatment group will be calculated. Higher ADPS scores indicate worse outcome., Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13 postdose|Number of Participants With Different Scale Ranges of the Patient Global Impression of Change (PGIC) Scale at Week 13, The PGIC is a validated outcome measure for treatment of pain in the acute pain setting. At the end of treatment, participants will rate their overall status on a scale of 1-7, where 1=very much improved and 7=very much worse using the standard PGIC questionnaire. Higher scores indicate worse outcome., Week 13 postdose
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| Locations: |
Phoenix, Arizona, 85018, United States|Colton, California, 92324, United States|Los Angeles, California, 90033, United States|Santa Ana, California, 92705, United States|Colorado Springs, Colorado, 80918, United States|Brooksville, Florida, 34601, United States|DeBary, Florida, 32713, United States|Hialeah, Florida, 33013, United States|Kissimmee, Florida, 34744, United States|Miami, Florida, 33144, United States|Grand Blanc, Michigan, 48439, United States|High Point, North Carolina, 27262, United States|Cincinnati, Ohio, 45224, United States|Wyomissing, Pennsylvania, 19610, United States|Greer, South Carolina, 29651, United States|Rapid City, South Dakota, 57702, United States|Knoxville, Tennessee, 37919, United States|Houston, Texas, 77098, United States|Plano, Texas, 75093, United States|Bellevue, Washington, 98007, United States|Charleston, West Virginia, 25304, United States|Morgantown, West Virginia, 26505, United States|Plovdiv, Bulgaria|Sevlievo, Bulgaria|Sofia, Bulgaria|Stara Zagora, Bulgaria|Varna, Bulgaria|Prague, Czechia|Ricany, Czechia|Budapest, Hungary|Nyiregyhaza, Hungary|Elblag, Poland|Kraków, Poland|Cluj-napoca, Romania|Johannesburg, South Africa|Pretoria, South Africa|Barcelona, Spain|Santiago de Compostela, Spain|Valencia, Spain
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