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Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)

This study has been completed.
Sponsor:
Information provided by:
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT00895830
First received: May 7, 2009
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

To assess the efficacy and safety of different doses of APD405 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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: APD405
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Acacia Pharma Ltd:

Primary Outcome Measures:
  • Experienced Post-operative Nausea or Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
IV
Experimental: 2
0.3mg dose level
Drug: APD405
IV
Experimental: 3
1mg dose level
Drug: APD405
IV
Experimental: 4
2mg dose level
Drug: APD405
IV
Experimental: 5
3mg dose level
Drug: APD405
IV

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age
  • Written informed consent
  • 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
  • Patients with at least 2 risk factors for PONV, defined as 2 of the following:

    1. Past history of PONV and/or motion sickness
    2. Non-smoking status
    3. Female gender
    4. Planned opiate use for post-operative analgesia
  • American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3)
  • Adequate hepatic and renal function

    • Alanine aminotransferase (ALT) <2.5 * upper limit normal (ULN)
    • Aspartate aminotransferase (AST) <2.5 * ULN
    • Bilirubin <1.5 * ULN
    • Creatinine <1.5 * ULN
  • Adequate haematological function

    • Haemoglobin ≥9.5 g/dL
    • White blood count 4.0-11.0 * 10^9/L
    • Platelet count ≥150 - 400 * 10^9/L
  • Ability and willingness to give written informed consent

Exclusion Criteria:

  • Patients undergoing outpatient/day case surgery
  • Patients undergoing surgery where the patient is expected to remain ventilated for a period after surgery
  • Patients undergoing intra-thoracic, transplant or central nervous system surgery
  • Patients receiving a local anaesthetic/regional neuraxial (intrathecal or epidural) block
  • Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks
  • Patients with a pre-existing vestibular disorder or history of dizziness
  • Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed
  • Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
  • Patients treated with regular anti-emetic therapy including corticosteroids
  • Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin
  • Patients with pre-existing nausea or vomiting 24 hours before surgery
  • Patients who are breast feeding or pregnant
  • Patients with a history of alcohol abuse
  • Patients diagnosed with Parkinson's disease
  • Patients who have received anti-cancer chemotherapy in the previous 4 weeks
  • Patients with pre-existing clinically significant cardiac arrhythmia
  • Patients with a history of epilepsy
  • 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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895830

Locations
United States, California
UCSF Medical Center at Mt Zion
San Francisco, California, United States, 94115
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Memorial Hermann-Memorial City Hospital
Houston, Texas, United States, 77024
France
University Hospital
Besançon, France
Hôpital mère enfant
Bron, France, 69500
Hôpital Huriez
Lille, France
University Hospital
Nancy, France
Hôpital FOCH
Paris, France
University Hospital
Reims, France
Hautepierre Hospital
Strasbourg, France, 67000
Germany
Charité - Universitätsmedizin
Berlin, Germany
Universität Heidelberg
Heidelberg, Germany
University of Leipzig
Leipzig, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Philipps University
Marburg, Germany
University Hospitals of Würzburg
Würzburg, Germany
Switzerland
Geneva University Hospitals
Geneva, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Sponsors and Collaborators
Acacia Pharma Ltd
Investigators
Principal Investigator: Martin Tramèr, MD University Hospital, Geneva
  More Information

No publications provided by Acacia Pharma Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT00895830     History of Changes
Other Study ID Numbers: DP10002
Study First Received: May 7, 2009
Results First Received: February 24, 2011
Last Updated: March 25, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on November 24, 2014