Post-operative nausea and vomiting (PONV) MedDRA version: 14.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: APD421
Product Code: APD421
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMISULPRIDE
CAS Number: 71675-85-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Acacia Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion 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: 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 of the following risk factors for PONV: a. Past history of PONV and/or motion sickness b. Habitual non-smoking status c. Female sex d. 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 =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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 amisulpride for any indication within the last 2 weeks 7. Patients who are allergic to amisulpride 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of different doses of APD421 in the prevention of PONV in patients at moderate to high-risk of PONV;Secondary Objective: Efficacy: to assess 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 opioids Sub-groups of the above variables over time Safety: to assess the nature and frequency of adverse events;Primary end point(s): The proportion of patients with no vomiting/retching and no use of rescue medication during the first 24 hours after completion of surgery (“complete response”). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: The incidence of total response (no vomiting/retching, no nausea and no use of rescue medication during the first 24 hours after completion of surgery). 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 opioids. Sub-group analyses of different endpoints at different timepoints (0–2 h, 2–6 h and 6–24 h). Safety: The nature and frequency of adverse events. | — |
Countries
France, Germany, United States
Contacts
Public ContactClinical Trials Information
Acacia Pharma Ltd
Outcome results
None listed