EUCTR2011-004267-71-DE进行中（未招募）不适用
Randomised, double-blind, placebo-controlled, dose-ranging Phase II study of APD421 (amisulpride for IV injection) for the prevention of post-operative nausea and vomiting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 < 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.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •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)
研究者
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