Post-operative nausea and vomiting MedDRA version: 9.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting
Conditions
Interventions
Product Name: APD405
Product Code: APD405
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Buspirone hydrochloride
CAS Number: 33386082
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Acacia Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients = 18 years of age 2. Written informed consent 3. Patients undergoing elective surgery under general anaesthesia requiring at least one overnight stay in hospital for either: a. Hysterectomy (any surgical technique) b. Cholecystectomy (any surgical technique) c. 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 risk factors for PONV, defined as 2 of the following: a. Past history of PONV and/or motion sickness b. Non-smoking status c. Female gender d. Planned opiate use for post-operative analgesia 5. American Society of Anesthesiologists (ASA) risk score I-III (see Appendix 3) 6. Adequate hepatic and renal function • Alanine aminotransferase (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients undergoing outpatient/day case surgery 2. Patients undergoing surgery where the patient is expected to remain ventilated in an intensive care unit 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 receiving buspirone hydrochloride for any indication within the last 4 weeks 6. Patients receiving monoamine oxidase inhibitor (MAOI) therapy currently or in the preceding 3 weeks 7. Patients who are allergic to buspirone hydrochloride or any of its excipients 8. Patients with a pre-existing vestibular disorder or history of dizziness 9. Patients that are expected to need a naso- or oral-gastric tube in situ after surgery is completed 10. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study 11. Patients treated with regular anti-emetic therapy including corticosteroids 12. Patients receiving CYP3A4 inducers or inhibitors within 7 days prior to study including but not limited to erythromycin, itraconazole, nefazodone, diltiazem, verapamil, rifampicin 13. Patients with pre-existing nausea or vomiting 24 hours before surgery 14. Patients who are breast feeding or pregnant 15. Patients with a history of alcohol abuse 16. Patients diagnosed with Parkinson’s disease 17. Patients who have received anti-cancer chemotherapy in the previous 4 weeks 18. Patients with pre-existing clinically significant cardiac arrhythmia 19. Patients with a history of epilepsy 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of different doses of APD405 in the prevention of PONV in patients at moderate to high risk of PONV, defined as the number of patients with no vomiting and no nausea (nausea defined as any score greater or equal to 4 on an 11-point verbal rating scale) during the first 24 hours after surgery.;Secondary Objective: To assess the effect of APD405 in terms of: The incidence and severity of nausea The incidence of vomiting. Time to first vomiting. The frequency of use of rescue medication. The above variables in a sub-group of patients receiving opiates for post-operative analgesia. Sub-groups of the above variables over time Safety: To assess the nature and frequency of adverse events of APD 405 patients at risk of PONV. Pharmacokinetics: To assess the pharmacokinetics of APD405 in patients receiving general anaesthesia. ;Primary end point(s): Number of patients with no vomiting and no nausea (nausea defined as any score greater than or equal to 4 on an 11-point VRS) during the first 24 hours after surgery. | — |
Countries
France, Germany
Outcome results
None listed