Phase II Dose-ranging Study of APD421 in PONV

February 14, 2019 updated by: Acacia Pharma Ltd

Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting

To assess the efficacy and safety of different doses of APD421 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Besançon, France
        • University Hospital
      • Bron, France, 69500
        • Hopital Mère Enfant
      • Lille, France
        • Hopital Huriez
      • Nancy, France
        • University Hospital
      • Paris, France
        • Hopital Foch
      • Strasbourg, France, 67000
        • Hautepierre Hospital
      • Aue, Germany
        • Helios Klinikum Aue
      • Berlin, Germany
        • Charité - Universitätsmedizin
      • Heidelberg, Germany
        • Universität Heidelberg
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen
      • Marburg, Germany
        • Philipps University
      • Würzburg, Germany
        • University Hospitals of Würzburg
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Male or female patients ≥ 18 years of age
  2. Ability and willingness to give written informed consent
  3. Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either:

    1. Hysterectomy (any surgical technique)
    2. Cholecystectomy (any surgical technique)
    3. Other elective surgery requiring overnight admission to hospital and scheduled to last at least 1 hour from induction of anaesthesia
  4. Patients with at least 2 of the following risk factors for PONV:

    1. Past history of PONV and/or motion sickness
    2. Habitual non-smoking status
    3. Female sex
    4. Expected to receive opioid analgesia post-operatively
  5. American Society of Anesthesiologists (ASA) risk score I-III
  6. Adequate cardiac, hepatic and renal function

    • QTc interval < 500 ms
    • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 5 x upper limit normal (ULN)
    • Bilirubin < 3 x ULN
    • Creatinine < 2 x ULN
  7. Adequate haematological function

    • Haemoglobin ≥ 9 g/dL
    • White blood count ≥ 3.0 x 109/L
    • Platelet count ≥ 100 x 109/L
  8. For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or 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) between the date of screening and at least 48 hours after administration of study drug.

Exclusion Criteria

  1. Patients undergoing outpatient/day case surgery
  2. Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
  3. Patients undergoing intra-thoracic, transplant or central nervous system surgery
  4. Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
  5. Patients who are expected to need a naso- or oral-gastric tube in situ after surgery is completed
  6. Patients receiving the active ingredient of APD421 for any indication within the last 2 weeks
  7. Patients who are allergic to the active ingredient or any of the excipients of APD421
  8. Patients with a pre-existing vestibular disorder or history of dizziness
  9. Patients with pre-existing nausea or vomiting in the 24 hours before surgery
  10. Patients treated with regular anti-emetic therapy including corticosteroids
  11. Patients being treated with medications which could induce 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
  12. Patients being treated with levodopa
  13. Patients who are pregnant or breast feeding
  14. Patients with a history of alcohol abuse
  15. Patients with pre-existing, clinically significant cardiac arrhythmia
  16. Patients diagnosed with Parkinson's disease
  17. Patients who have received anti-cancer chemotherapy in the previous 4 weeks
  18. Patients with a history of epilepsy
  19. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
  20. Patients who have participated in a previous study within the last 28 days (French sites only: Patients who have participated in a previous study within the last 6 months, if required by national or local regulations)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
IV
Experimental: Low dose APD421
1mg dose level
IV
Experimental: Mid Dose APD421
5mg dose level
IV
Experimental: High Dose APD421
20mg dose level
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative Nausea or Vomiting
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Peter Kranke, MD, University Hospitals of Würzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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