Randomised, double-blind, placebo-controlled, Phase II study to assess the safety and efficacy of different doses of intravenous APD405 (buspirone for IV injection) for the prevention of post-operative nausea and vomiting
- Conditions
- Post-operative nausea and vomitingMedDRA version: 9.1Level: LLTClassification code 10036901Term: Prophylaxis against postoperative nausea and vomiting
- Registration Number
- EUCTR2008-007770-37-FR
- Lead Sponsor
- Acacia Pharma Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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) <2.5 x upper limit normal (ULN)
•Aspartate aminotransferase (AST) <2.5 x ULN
•Bilirubin <1.5 x ULN
•Creatinine <1.5 x UN
7.Adequate haematological function
•Haemoglobin =9.5 g/dL
•White blood count 4.0-11.0 x 109/L
•Platelet count =150 - 400 x 109/L
8.Ability and willingness to give written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 arrythmia (formally diagnosed)
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method