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Trial record 2 of 5 for:    APD421 | Interventional Studies | Phase 3

Study of APD421 as PONV Treatment (Prior Prophylaxis)

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ClinicalTrials.gov Identifier: NCT02646566
Recruitment Status : Completed
First Posted : January 5, 2016
Results First Posted : December 18, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 5, 2016
Results First Submitted Date  ICMJE September 26, 2018
Results First Posted Date  ICMJE December 18, 2018
Last Update Posted Date January 21, 2019
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
Number of Participants With Complete Response (Success of Initial PONV Treatment) [ Time Frame: 0-24 hours after administration of study medication ]
The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Complete response [ Time Frame: 0-24 hours after treatment ]
No further emesis or use of rescue medication
Change History Complete list of historical versions of study NCT02646566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
  • Number of Participants With Complete Response 0-2 Hrs [ Time Frame: 0-2 hours after administration of study medication ]
    Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.
  • Number of Participants With Complete Response 0-4 Hrs [ Time Frame: 0-4 hours after administration of study medication ]
    Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication.
  • Number of Participants With Complete Response 0-6 Hrs [ Time Frame: 0-6 hours after administration of study medication ]
    Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication.
  • Time to Treatment Failure [ Time Frame: 0-24 hours after study drug administration ]
    Time to first violation of the criteria for complete response
  • Number of Patients With Incidence of Emesis [ Time Frame: 30 mins to 24 hours after study drug administration ]
    Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication
  • Number of Patients Receiving Rescue Medication [ Time Frame: 0-24 hours after study drug administration ]
    Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period
  • Number of Patients With an Incidence of Significant Nausea [ Time Frame: 30 mins to 24 hours after study drug administration ]
    Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
  • Number of Patients With an Incidence of Nausea [ Time Frame: 30 mins to 24 hours after drug administration ]
    Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
  • Maximum Severity of Nausea [ Time Frame: 30 mins to 24 hours after study drug administration ]
    Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
  • Evolution Score of Nausea (0-180 Mins) [ Time Frame: 0-180 minutes after study drug administration ]
    The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.
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 Study of APD421 as PONV Treatment (Prior Prophylaxis)
Official Title  ICMJE Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis
Brief Summary Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.
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: Treatment
Condition  ICMJE Postoperative Nausea and Vomiting
Intervention  ICMJE
  • Drug: APD421
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: APD421 standard
    Single (standard) dose IV APD421
    Intervention: Drug: APD421
  • Experimental: APD421 high
    Single (high) dose IV APD421
    Intervention: Drug: APD421
  • Placebo Comparator: Placebo
    Single 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: January 23, 2017)
705
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
580
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Male or female patients ≥ 18 years of age
  • Provision of written informed consent
  • Patients scheduled to undergo elective surgery (open or laparoscopic technique) under general anaesthesia (other than total intravenous anaesthesia with propofol) expected to last at least one hour from induction of anaesthesia to extubation
  • Patients judged by the investigator to have a moderate or high risk of experiencing PONV. In forming this judgment, investigators should pay particular attention to risk factors such as a past history of PONV and/or motion sickness; habitual non-smoking status; female sex; and likely use of opioid analgesia post-operatively.
  • For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (as defined in ICH M3 guidance, e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner), combined oral contraceptive pill, a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom, or any other method or combination of methods with a failure rate generally considered to be <1% per year) between the date of screening and at least 48 hours after administration of study drug
  • In order to be eligible for randomisation, subjects must also:

    (i) have experienced a first episode of PONV not more than 24 hours after the end of their operation (wound closure) and prior to discharge from hospital ("qualifying PONV episode"), for which they have not already received any anti-emetic treatment; and (ii) not have received any dopamine-antagonist agent likely to prevent or treat nausea or vomiting (given as prophylaxis or otherwise) in the period from 24 hours prior to the start of their operation up to the time of the qualifying PONV episode.

Exclusion Criteria:

  • Patients scheduled to undergo transplant surgery or any surgery where post-operative emesis may pose a significant danger to the patient
  • Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
  • Patients who have received APD421 active ingredient for any indication within the last 2 weeks
  • Patients who are allergic to APD421 active ingredient or any of the excipients of APD421
  • Patients with a significant, ongoing history of vestibular disease or dizziness
  • Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
  • Patients with documented or suspected alcohol or substance abuse within the past 6 months.
  • Patients with direct or indirect evidence of clinically significant hypokalaemia, such as a serum potassium level < 3.0 mmol/L.
  • Patients who have received in the post-operative period, and prior to receiving study drug, any medication with a substantial risk of inducing torsades de pointes, including Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide; Class III antiarrhythmic agents such as amiodarone and sotalol; and other medications such as bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin, etc.
  • Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome.
  • Patients who are pregnant or breast feeding.
  • Patients being treated with levodopa.
  • Patients diagnosed with Parkinson's disease.
  • Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks.
  • Patients with a history of epilepsy.
  • Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study.
  • Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations).
  • Where local laws/regulations require: patients under legal protection.
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 NCT02646566
Other Study ID Numbers  ICMJE DP10019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Acacia Pharma Ltd
Study Sponsor  ICMJE Acacia Pharma Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gabriel Fox, MB BChir Acacia Pharma Ltd
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