A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Scar PreventionScar Reduction
Interventions
DRUG

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.

DRUG

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.

Trial Locations (5)

27834

Orthopaedics East, PA, Greenville

32720

Florida Research Associates, DeLand

32822

Atlas Orthopedics & Sports Medicine, Orlando

78759

Texas Orthopedics, Sports & Rehab Assoc., Austin

91105

Lotus Clinical Research, Inc., Pasadena

Sponsors
All Listed Sponsors
lead

Capstone Therapeutics

INDUSTRY