US Phase III Study of APD421 in PONV

PONV Clinical Trial

Official title:

Randomized, 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: NCT01991860
• Other study ID #: DP10015
• Status: Completed
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: January 2014

Study information

• Verified date: January 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: 364
• 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
• Postoperative Nausea and Vomiting

Intervention

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

Locations

Country	Name	City	State
United States	Duke	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Acacia Pharma Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?2 test with Yates's continuity correction, and with a two-sided significance level of 5%.	24 hours after the end of surgery
Secondary	Number of Participants With no Nausea.	Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No nausea" means no score = 1.	24 hours after end of surgery
Secondary	Number of Participants With no Emesis	Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)	24 hours after end of surgery
Secondary	Number of Participants With no Use of Rescue Medication	Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.	24 hours after end of surgery
Secondary	The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication	No occurrence of vomiting/retching, no nausea score = 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.	24 hours after the end of surgery
Secondary	The Number of Participants With no Significant Nausea	Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "No significant nausea" means no score = 4.	24 hours after the end of surgery
Secondary	Number of Participants With "Total Response"	Total response is defined as no occurrence of vomiting/retching, no nausea score = 1 and no use of rescue medication.	24 hours after the end of surgery