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US Phase III Study of APD421 in PONV

NCT01991860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2019-02-12

Study results available
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Summary

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Conditions

  • PONV

Interventions

DRUG

APD421- Amisulpride for IV injection

APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

DRUG

Placebo

Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Tong J Gan, MD · Duke University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

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 NCT01991860 on ClinicalTrials.gov