150
Participants
Start Date
January 31, 2009
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
Placebo
Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
AZX100
AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.
Orthopaedics East, PA, Greenville
Florida Research Associates, DeLand
Atlas Orthopedics & Sports Medicine, Orlando
Texas Orthopedics, Sports & Rehab Assoc., Austin
Lotus Clinical Research, Inc., Pasadena
Lead Sponsor
Capstone Therapeutics
INDUSTRY