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

Tracking Information

• First Submitted Date: November 11, 2013
• First Posted Date: November 25, 2013
• Results First Submitted Date: August 7, 2018
• Results First Posted Date: September 6, 2018
• Last Update Posted Date: February 12, 2019
• Study Start Date: August 2013
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 18, 2019)

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%.

Original Primary Outcome Measures (submitted: November 18, 2013)

Complete Response (protection from PONV) [ Time Frame: 24 hours ]

Proportion of patients with no PONV in the 24-hour period after end of surgery

Current Secondary Outcome Measures (submitted: January 18, 2019)

• 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.
• 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)
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: US Phase III Study of APD421 in PONV
• Official Title: Randomized, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: PONV

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
  Other Name: Amisulpride for IV injection
• Drug: Placebo
  Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

Study Arms

• Experimental: APD421
  APD421 (amisulpride), at 5mg given by single intravenous (IV) administration by slow push over one minute at induction of anaesthesia.
  Intervention: Drug: APD421- Amisulpride for IV injection
• Placebo Comparator: Placebo
  Matching placebo given by single IV administration by slow push over one minute at induction of anaesthesia
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 9, 2015): 364
• Original Estimated Enrollment (submitted: November 18, 2013): 340
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01991860
• Other Study ID Numbers: DP10015
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Acacia Pharma Ltd
• Original Responsible Party: Same as current
• Current Study Sponsor: Acacia Pharma Ltd
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Acacia Pharma Ltd
• Verification Date: January 2019