European Phase III Study of APD421 in PONV

PONV Clinical Trial

Official title:

Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991821
• Other study ID #: DP10014
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2019
• Source: Acacia Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• PONV

Intervention

Drug:
• APD421

• Placebo

Locations

Country	Name	City	State
France	CHU de Hautepierre	Strasbourg
Germany	University Hospitals of Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response (no Emesis, Significant Nausea or Rescue Medication)	The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.	24 hours after end of surgery
Secondary	Complete Response (no Emesis or Rescue Medication)		24 hrs after end of surgery
Secondary	Total Response (no Emesis, Nausea or Rescue Medication)		24 hrs after end of surgery
Secondary	Incidence of Emesis (Vomiting/Retching)	An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery	24 hours after end of surgeryry
Secondary	Incidence of Nausea	Count of patients experiencing an episode of nausea scored = 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery	24 hours after end of surgery
Secondary	Incidence of Significant Nausea	Count of participants with nausea score = 4 on 0-10 verbal response scale	24 hours after end of surgery
Secondary	Use of Rescue Medication		24 hours after end of surgery