Status:
COMPLETED
Dose-ranging Study of APD405 in Post-operative Nausea and Vomiting (PONV)
Lead Sponsor:
Acacia Pharma Ltd
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 under...
Eligibility Criteria
Inclusion
- 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:
- Hysterectomy (any surgical technique)
- Cholecystectomy (any surgical technique)
- 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:
- Past history of PONV and/or motion sickness
- Non-smoking status
- Female gender
- 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
- 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)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00895830
Start Date
May 1 2009
End Date
November 1 2009
Last Update
March 29 2011
Active Locations (18)
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1
UCSF Medical Center at Mt Zion
San Francisco, California, United States, 94115
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Memorial Hermann-Memorial City Hospital
Houston, Texas, United States, 77024
4
University Hospital
Besançon, France