Age: 40-80

Number of visits: 6

Payment: $50 to $100

Diagnosis: OA of the Knee

#subjects: 10


Protocol #       SM04690-OA-04

Title:            A Phase 2, 24-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis

Coordinator:   Michelle De La Cruz

Type of Volunteer:  

  • Diagnosis of femorotibial OA in the knee
  • Males or females between 40 and 80 years of age, inclusive
  • Primary source of pain throughout the body due to OA in the knee
  • OA knee pain for at least 26 weeks prior to Screening Visit 1
  • Subject willing to use a daily electronic diary throughout the screening period and 24-week study duration


Length of Study:     Approximately 6 months with possibility of enrolling in the EXT study that last 5 years

Specific Exclusions:

  • Body Mass index > 35
  • Complete or partial joint replacement in either knee
  • Any surgery in either knee within 26 weeks prior to any study injection
  • Any planned surgery during the study period
  • Currently requires regular use of ambulatory assistive devices, use of a lower extremity prosthesis, and/or a structural patellofemoral knee brace
  • Radiographic disease Stage 0, 1, or 4 in the target knee at Screening Visit 1 according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
  • Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 8 weeks prior to any study injection, throughout the screening period and 24-week study duration


  • Prohibited medications:
    • Treatment with intra-articular corticosteroids within 12 weeks prior to Screening Visit 1.