NCT01991860

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

September 6, 2018

Completed
Last Updated

February 12, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

November 11, 2013

Results QC Date

August 7, 2018

Last Update Submit

January 18, 2019

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Complete Response

    The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.

    24 hours after the end of surgery

Secondary Outcomes (6)

  • Number of Participants With no Nausea.

    24 hours after end of surgery

  • Number of Participants With no Emesis

    24 hours after end of surgery

  • Number of Participants With no Use of Rescue Medication

    24 hours after end of surgery

  • The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication

    24 hours after the end of surgery

  • The Number of Participants With no Significant Nausea

    24 hours after the end of surgery

  • +1 more secondary outcomes

Study Arms (2)

APD421

EXPERIMENTAL

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

Drug: APD421- Amisulpride for IV injection

Placebo

PLACEBO COMPARATOR

Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia

Drug: Placebo

Interventions

APD421- Amisulpride for IV injectionDRUG

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

Also known as: Amisulpride for IV injection
APD421
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients ≥ 18 years of age
  • Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

You may not qualify if:

  • Patients scheduled for outpatient/day case surgery
  • Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
  • Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
  • Patients who are expected to remain ventilated for a period after surgery
  • Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke

Durham, North Carolina, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Injections, IntravenousAmisulpride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInjectionsBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and Caveats

There were no limitations and caveats in this study.

Results Point of Contact

Title
Dr Gabriel Fox
Organization
Acacia Pharma Ltd
Gabrielfox@acaciapharma.com
44-(0)1223-919764

Study Officials

  • Tong J Gan, MD

    Duke University Medical College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 25, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 12, 2019

Results First Posted

September 6, 2018

Record last verified: 2019-01

Locations

US(1)