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

Summary

The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing scars that were made from trocars following arthroscopic shoulder surgery.

Timeline

Start

2009-01

Primary completion

2010-12

Completion

2010-12

Outcome

Missed primary endpoint

registry PSAS Results for Placebo Trocar Scars vs PSAS Results for 3 mg AZX100 Trocar Scars; p = 0.57 NCT00811577 ↗

registry PSAS Results for Placebo Trocar Scars vs PSAS Results for 10 mg AZX100 Trocar Scars; p = 0.56 NCT00811577 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AZX100	Unknown	3 mg	Other
Subject	AZX100	Unknown	10 mg	Other

Indications

No indication recorded.