Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

• ClinicalTrials.gov Identifier: NCT02337062
• Recruitment Status: Completed
• First Posted: January 13, 2015
• Results First Posted: August 4, 2017
• Last Update Posted: March 20, 2019
• Sponsor: Acacia Pharma Ltd
• Information provided by (Responsible Party): Acacia Pharma Ltd

Tracking Information

• First Submitted Date: January 9, 2015
• First Posted Date: January 13, 2015
• Results First Submitted Date: July 7, 2017
• Results First Posted Date: August 4, 2017
• Last Update Posted Date: March 20, 2019
• Study Start Date: February 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 14, 2019)

Number of Participants With Complete Response [ Time Frame: 24 hours after the end of surgery ]

Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)

Original Primary Outcome Measures (submitted: January 12, 2015)

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: March 7, 2019)

• Number of Participants With Emesis [ Time Frame: 24 hours after the 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 Receiving Rescue Medication [ Time Frame: 24 hours after the end of surgery ]
  Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential
• Number of Participants With Any 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. "Any nausea" means a score ≥ 1.
• Number of Participants With Significant 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. "Significant nausea" means a score ≥ 4.
• Time to First Violation of Criteria for PONV [ Time Frame: 24 hours after end of surgery ]
  Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery

• 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: Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
• Official Title: Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients
• Brief Summary: A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (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
• Drug: Placebo

Study Arms

• Experimental: APD421 + standard anti-emetic
  Single dose of IV APD421
  Intervention: Drug: APD421
• Placebo Comparator: Placebo + standard anti-emetic
  Single dose of IV placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 3, 2017): 1147
• Original Estimated Enrollment (submitted: January 12, 2015): 1100
• Actual Study Completion Date: September 2015
• Actual Primary Completion Date: September 2015 (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
• Patients with at least 3 "Apfel" risk factors for PONV

Exclusion Criteria:

• Patients scheduled to undergo transplant 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: France, Germany, United States

Administrative Information

• NCT Number: NCT02337062
• Other Study ID Numbers: DP10017
• 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: Peter Kranke, MD; Würzburg University Hospitals

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