A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Dose Finding Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Laparoscopic Colorectal Surgery

NCT02992041 Phase 2 COMPLETED

The purpose of this phase 2 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections. The study is designed as randomized, double-blind, parallel, placebo-controlled study.

Details

Lead sponsor	Vivozon, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	69
Start date	2016-12-27
Completion	2018-04-26

Conditions

• Post-Operative Pain

Interventions

• VVZ-149 Injections
• Placebo

Primary outcomes

• area under the curve (AUC) of Pain Intensity — 0hr=start of PCA, 1hr and 2 hours
  area under the curve (AUC) of Pain Intensity using Numeric Pain Rating Scale (NRS, 0-10 at rest) measured up to 2 hours post-initiation of PCA

Countries

United States