Phase II Dose-ranging Study of APD421 in PONV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acacia Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01510704
First received: January 12, 2012
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Postoperative Nausea and Vomiting
Drug: APD421
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, Dose-ranging Phase II Study of APD421 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:
  • Post-operative Nausea or Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
IV
Experimental: Low dose APD421
1mg dose level
Drug: APD421
IV
Experimental: Mid Dose APD421
5mg dose level
Drug: APD421
IV
Experimental: High Dose APD421
20mg dose level
Drug: APD421
IV

  Eligibility

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

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)
  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: NCT01510704

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
France
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
Germany
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
Investigators
Principal Investigator: Peter Kranke, MD University Hospitals of Würzburg
  More Information

No publications provided by Acacia Pharma Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Acacia Pharma Ltd
ClinicalTrials.gov Identifier: NCT01510704     History of Changes
Other Study ID Numbers: DP10006
Study First Received: January 12, 2012
Results First Received: May 15, 2013
Last Updated: May 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014