US Phase III Study of APD421 in PONV

Phase 3

Completed

• Conditions: PONV
• Interventions: Drug: APD421- Amisulpride for IV injection; Drug: Placebo

• Registration Number: NCT01991860
• Lead Sponsor: Acacia Pharma Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Disposition First Submitted: 2016-07-28
• Disposition First Submitted QC: 2016-07-28
• Disposition First Posted: 2016-07-29
• Results First Submitted: 2018-08-07
• Results First Submitted QC: 2018-09-05
• Results First Posted: 2018-09-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APD421	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	Placebo	Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia

Primary Outcome Measures

Name	Time	Method
Number of Participants With Complete Response	24 hours after the end of surgery	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%.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With "Total Response"	24 hours after the end of surgery	Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.
Number of Participants With no Nausea.	24 hours after end of surgery	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.
Number of Participants With no Emesis	24 hours after end of surgery	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)
Number of Participants With no Use of Rescue Medication	24 hours after end of surgery	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.
The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication	24 hours after the end of surgery	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.
The Number of Participants With no Significant Nausea	24 hours after the end of surgery	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.

Trial Locations

Locations (1)

Duke; 🇺🇸 Durham, North Carolina, United States