DFA-02 in Patients Undergoing Colorectal Surgery

Phase 1/2 Completed 30 enrolled Dr. Reddy's Laboratories Limited Duke Clinical Research Institute · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.

Timeline

Start: 2012-02
Primary completion: 2013-04
Completion: 2013-06

Publications

Bennett-Guerrero E, Minkowitz HS, Segura-Vasi AM, Marcet JE, White JA, Corey GR, Allenby KS. A randomized, double-blind, placebo controlled safety, tolerability, and pharmacokinetic dose escalation study of a gentamicin vancomycin gel in patients undergoing colorectal surgery. Perioper Med (Lond). 2016 Jun 16;5:17. doi: 10.1186/s13741-016-0043-2. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DFA-02	Unknown	10 ml	Topical
Subject	DFA-02	Unknown	20 ml	Topical
Subject	DFA-02	Unknown	30 ml	Topical

Indications

No indication recorded.