US Phase III Study of APD421 in PONV

• ClinicalTrials.gov Identifier: NCT01991860
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Results First Posted: September 6, 2018
• Last Update Posted: February 12, 2019
• Sponsor: Acacia Pharma Ltd
• Information provided by (Responsible Party): Acacia Pharma Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PONV	Drug: APD421- Amisulpride for IV injection; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 364 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
• Study Start Date: August 2013
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: APD421; 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; APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia; Other Name: Amisulpride for IV injection
Placebo Comparator: Placebo; Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia	Drug: Placebo; Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Complete Response [ Time Frame: 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 :

1. Number of Participants With no Nausea. [ Time Frame: 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.
2. Number of Participants With no Emesis [ Time Frame: 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)
3. Number of Participants With no Use of Rescue Medication [ Time Frame: 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.
4. The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication [ Time Frame: 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.
5. The Number of Participants With no Significant Nausea [ Time Frame: 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.
6. Number of Participants With "Total Response" [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, North Carolina

Duke

Durham, North Carolina, United States

Sponsors and Collaborators

Acacia Pharma Ltd

Investigators

• Principal Investigator: Tong J Gan, MD; Duke University Medical College

More Information

• Responsible Party: Acacia Pharma Ltd
• ClinicalTrials.gov Identifier: NCT01991860
• Other Study ID Numbers: DP10015
• First Posted: November 25, 2013
• Results First Posted: September 6, 2018
• Last Update Posted: February 12, 2019
• Last Verified: January 2019

Additional relevant MeSH terms:

Amisulpride; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antidepressive Agents, Second-Generation; Antidepressive Agents