A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
The study schedule consists of a Screening Period (up to 14 days), a blinded 4- week
Titration-to-Effect Period with weekly visits, a blinded 4-week Maintenance Treatment Period
at the optimal dose level determined for each patient, and a 1-week Follow-up Period.
Eligible patients will be randomized to receive either CR845 or placebo in a 2:1 ratio. Every
patient will be started on a 1-mg dose of CR845 or matching placebo. During the
post-randomization Titration-to-Effect period, the dose of study drug may be increased to 2.5
mg or 5 mg in a double-blind fashion. Patients may know their dose is being changed but will
not know whether they were randomization to active study drug or placebo. Approximately 330
patients will be enrolled in this study.