Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Utilizing Patient-Reported and Radiographic Outcomes to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subject

  • STATUS
    Recruiting
Updated on 19 June 2019

Summary

Phase 3, 56-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Utilizing Patient-Reported and Radiographic Outcomes to Evaluate the Efficacy and Safety of a Single Injection of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

Details
Condition Osteoarthritis
Clinical Study IdentifierTX223540
Last Modified on19 June 2019

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 80 yrs?
Gender: Male or Female
Do you have Osteoarthritis?
Male/Female 40-80 years of age
BMI ≤ 40
K-L ≥ 2-3 and mJSW between 2-4mm assessed by central reader
Moderate to severe pain in the index knee associated with OA for at least 26 weeks prior to screening

Exclusion Criteria

Significant malalignment of target knee (varus > 10°, valgus > 10°) at screening
Any IA injection into the target knee (includes:visco inj, PRP, and stem cell therapies within 26 weeks prior to Screening.No CSI less than 12 weeks prior to Screening Visit
No aspirations to target knee <12 wks prior to screening
No hx of cancer <5 Years
Current use, or use within 12 weeks prior to Screening Visit 1, of centrally acting analgesics (See attached Appendix 1)
Hx of anticonvulsants (See attached Appendix 1) ≤12 weeks prior to Screening
Hx of Opioids ≤12 weeks prior to Screening
Hx of Topical local anesthetic agents (gels, creams, or patches) ≤7 days of Screening
No hx of peripheral neuropathy, Symptomatic DDD
No hx of other inflammatory disease(s)
If using NSAIDs and/or acetaminophen, subjects must be on a stable regimen for ≥4 weeks prior to Screening
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