Rotator Cuff Repair of the Shoulder Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder
The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory
study in patients undergoing arthroscopic rotator cuff repair surgery.
Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975
will be escalated in a protocolized manner based on safety and tolerability.
Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of
4975 or placebo. All patients will be observed in the hospital for at least two days
following surgery for safety, tolerability, and efficacy assessments. In addition there will
be two planned follow-up visits after hospital discharge.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment