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Phase II Dose-ranging Study of APD421 in PONV

NCT01510704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2019-03-05

Study results available
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Summary

To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

APD421

IV

DRUG

Placebo

IV

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Peter Kranke, MD · University Hospitals of Würzburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States
  • France
  • Germany

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 NCT01510704 on ClinicalTrials.gov