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Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain Following Gastrectomy

NCT02522598 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-09-29

No results posted yet for this study

Summary

VVZ-149 is a novel analgesic drug candidate that shows a potential analgesic activity inhibiting GlyT2 and 5HT2A simultaneously. These target receptors have been known to play important roles in induction and transmission of pain signals. There have been many efforts to develop selective drugs to treat pain, but usually unsuccessful due to the lack of efficacy or limitations of single-target approach for new drug discovery. VVZ-149 is expected to be a dual-target drug, demonstrated having a potential synergism between GlyT2 and 5HT2A to maximize an antinociceptive effect in the in vivo animal models. In Phase 1 conducted among healthy subjects, safety and tolerability were confirmed. Phase 2 was designed as a randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the efficacy and safety of the analgesic drug VVZ-149 injection.

Conditions

  • Post-Operative Pain

Interventions

DRUG

VVZ-149 injections

Colorless, transparent liquid in water for injection

DRUG

Placebo

water for injection

Sponsors & Collaborators

  • Vivozon, Inc.

    lead INDUSTRY

Principal Investigators

  • Seonjun Bae, MD, PhD · Yonsei University Health System, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • South Korea

Study Locations

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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 NCT02522598 on ClinicalTrials.gov