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Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery

NCT02489526 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-08-25

No results posted yet for this study

Summary

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.

Conditions

  • Post-Operative Pain

Interventions

DRUG

VVZ-149 Injections

Experimental group will receive a loading dose of 1.8 mg/kg VVZ-149 intravenous infusion for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h VVZ-149 intravenous infusion for 7.5 hours.

DRUG

Placebo

Placebo group will receive the corresponding amount of placebo.

Sponsors & Collaborators

  • Vivozon, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-28
Primary Completion
2016-08-31
Completion
2016-08-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489526 on ClinicalTrials.gov