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Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

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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:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 13, 2015
Results First Submitted Date  ICMJE July 7, 2017
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date March 20, 2019
Study Start Date  ICMJE February 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE PONV
Intervention  ICMJE
  • Drug: APD421
  • Drug: Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
1147
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2015)
1100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02337062
Other Study ID Numbers  ICMJE DP10017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Acacia Pharma Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Acacia Pharma Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Kranke, MD Würzburg University Hospitals
PRS Account Acacia Pharma Ltd
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP