Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 5 for:    APD421 | Interventional Studies | Phase 3

Study of APD421 as PONV Treatment (no Prior Prophylaxis)

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: NCT02449291
Recruitment Status : Completed
First Posted : May 20, 2015
Results First Posted : December 18, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd

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 not had prior PONV prophylaxis.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: APD421 Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 no Prior Prophylaxis
Study Start Date : September 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APD421 standard
Single (standard) dose IV APD421
Drug: APD421
Experimental: APD421 high
Single (high) dose IV APD421
Drug: APD421
Placebo Comparator: Placebo
Single IV placebo
Drug: Placebo



Primary Outcome Measures :
  1. Complete Response (Success of Initial PONV Treatment) [ Time Frame: 0-24 hours after treatment ]
    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.


Secondary Outcome Measures :
  1. 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.

  2. Number of Participants With Complete Response 2-24 Hrs [ Time Frame: 2-24 hours after administration of study medication ]
    Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) and no administration of anti-emetic rescue medication from 2 to 24 hours after administration of study medication.

  3. Time to Treatment Failure [ Time Frame: 0-24 hours after study drug administration ]
    Time to first violation of the criteria for complete response

  4. Number of Patients Experiencing 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

  5. Number of Participants Using Rescue Medication [ Time Frame: 0-24 hours after study drug administration ]
    Proportion of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period

  6. Incidence of Significant Nausea [ Time Frame: 30 mins to 24 hours after study drug administration ]
    Proportion 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.

  7. Incidence of Nausea [ Time Frame: 30 mins to 24 hours after study drug administration ]
    Proportion 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.

  8. 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.

  9. Evolution Score of Nausea (0-30 Mins) [ Time Frame: 0-30 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 four pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 low to moderate 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 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 agent likely to prevent or treat nausea or vomiting (given as prophylaxis or otherwise) in the period from 12 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 being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing within one week prior to surgery
  • Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma
  • Patients being treated with levodopa
  • Patients who are pregnant or breast feeding
  • Patients with documented or suspected alcohol or substance abuse within the past 6 months
  • Patients with a documented, clinically significant cardiac arrhythmia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449291


Locations
Layout table for location information
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
France
CHU de Hautepierre
Strasbourg, France
Germany
Universität Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
Layout table for investigator information
Principal Investigator: Keith Candiotti, MD University of Miami

Layout table for additonal information
Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT02449291     History of Changes
Other Study ID Numbers: DP10018
First Posted: May 20, 2015    Key Record Dates
Results First Posted: December 18, 2018
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes