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US Phase III Study of APD421 in PONV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Tracking Information
First Submitted Date  ICMJE November 11, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE August 7, 2018
Results First Posted Date  ICMJE September 6, 2018
Last Update Posted Date February 12, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History Complete list of historical versions of study NCT01991860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE US Phase III Study of APD421 in PONV
Official Title  ICMJE 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  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- 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  ICMJE
  • 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

*   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: January 9, 2015)
364
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
340
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (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 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  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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01991860
Other Study ID Numbers  ICMJE DP10015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acacia Pharma Ltd
Study Sponsor  ICMJE Acacia Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tong J Gan, MD Duke University Medical College
PRS Account Acacia Pharma Ltd
Verification Date January 2019

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