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Phase II Dose-ranging 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. Identifier: NCT01510704
Recruitment Status : Completed
First Posted : January 16, 2012
Results First Posted : July 18, 2013
Last Update Posted : March 5, 2019
Information provided by (Responsible Party):
Acacia Pharma Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: APD421 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo

Experimental: Low dose APD421
1mg dose level
Drug: APD421

Experimental: Mid Dose APD421
5mg dose level
Drug: APD421

Experimental: High Dose APD421
20mg dose level
Drug: APD421

Primary Outcome Measures :
  1. Post-operative Nausea or Vomiting [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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

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)

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 identifier (NCT number): NCT01510704

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
University Hospital
Besançon, France
Hôpital mère enfant
Bron, France, 69500
Hôpital Huriez
Lille, France
University Hospital
Nancy, France
Hôpital FOCH
Paris, France
Hautepierre Hospital
Strasbourg, France, 67000
HELIOS Klinikum Aue
Aue, Germany
Charité - Universitätsmedizin
Berlin, Germany
Universität Heidelberg
Heidelberg, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Philipps University
Marburg, Germany
University Hospitals of Würzburg
Würzburg, Germany
Sponsors and Collaborators
Acacia Pharma Ltd
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Principal Investigator: Peter Kranke, MD University Hospitals of Würzburg

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Acacia Pharma Ltd Identifier: NCT01510704     History of Changes
Other Study ID Numbers: DP10006
First Posted: January 16, 2012    Key Record Dates
Results First Posted: July 18, 2013
Last Update Posted: March 5, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes