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

NCT02489526 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	60
Start date	2015-09-28
Completion	2016-08-15

Conditions

• Post-Operative Pain

Interventions

• VVZ-149 Injections
• Placebo

Primary outcomes

• Sum of Pain Intensity Difference over 8-hours post-dose (SPID8) — 8 hours post-dose
  SPID8 using Numerical Pain Rating Scale (NRS, 0-10) measured up to 8 hours post-dose

Countries

United States