Phase 3 Study 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

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

This is a 56-week, placebo controlled study to evaluate the efficacy and safety of the SM04690 injectable suspension 0.07 mg dose in the treatment of knee osteoarthritis (OA).  Both patient-reported and radiographic measures will be used to assess efficacy. 

Subjects will participate in a 10- to 22-day screening period followed by a single injection and a 6-month evaluation period. Clinic visits will be scheduled at screening visit 1, screening visit 2, Day 1, and weeks 4, 12 and 24. Radiographic images of the knee will be performed at screening visit 1 and week 24. 

Subjects will be required to complete a daily electronic diary throughout the study. 

Description

For more information, please contact the study coordinator, Deb, at deb@alpineresearch.com

Details
Condition Osteoarthritis
Clinical Study IdentifierTX223533
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have a clinical and radiographic diagnosis of femorotibial OA in the target knee at screening
OA of the knee is not to be secondary to any rheumatologic conditions
Subjects must be ambulatory, single assistive devices such as canes are allowed if needed less than 50% of the time
Subjects requiring a walker are excluded
Primary source of pain throughout the body must be due to OA in the target knee
Subjects must have a BMI under 35
Subjects excluded if they have had a single or bilateral, partial or complete knee or hip replacement
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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