NCT02646566已完成3 期
Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 705
- 试验地点
- 8
- 主要终点
- Number of Participants With Complete Response (Success of Initial PONV Treatment)
研究概览
简要总结
Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients scheduled to undergo transplant surgery or any surgery where post-operative emesis may pose a significant danger to the patient
- •Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
- •Patients who have received APD421 active ingredient for any indication within the last 2 weeks
- •Patients who are allergic to APD421 active ingredient or any of the excipients of APD421
- •Patients with a significant, ongoing history of vestibular disease or dizziness
- •Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma.
- •Patients with documented or suspected alcohol or substance abuse within the past 6 months.
- •Patients with direct or indirect evidence of clinically significant hypokalaemia, such as a serum potassium level < 3.0 mmol/L.
- •Patients who have received in the post-operative period, and prior to receiving study drug, any medication with a substantial risk of inducing 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, etc.
- •Patients who have a documented, clinically significant cardiac arrhythmia or congenital long QT syndrome.
- •Patients who are pregnant or breast feeding.
- •Patients being treated with levodopa.
- •Patients diagnosed with Parkinson's disease.
- •Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks.
- •Patients with a history of epilepsy.
- •Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study.
- •Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations).
- •Where local laws/regulations require: patients under legal protection.
研究组 & 干预措施
APD421 standard
Experimental
Single (standard) dose IV APD421
干预措施: APD421 (Drug)
APD421 high
Experimental
Single (high) dose IV APD421
干预措施: APD421 (Drug)
Placebo
Placebo Comparator
Single IV placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Complete Response (Success of Initial PONV Treatment)
时间窗: 0-24 hours after administration of study medication
The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.
次要结局
- Number of Patients With Incidence of Emesis(30 mins to 24 hours after study drug administration)
- Number of Participants With Complete Response 0-2 Hrs(0-2 hours after administration of study medication)
- Number of Participants With Complete Response 0-4 Hrs(0-4 hours after administration of study medication)
- Number of Participants With Complete Response 0-6 Hrs(0-6 hours after administration of study medication)
- Time to Treatment Failure(0-24 hours after study drug administration)
- Number of Patients Receiving Rescue Medication(0-24 hours after study drug administration)
- Number of Patients With an Incidence of Significant Nausea(30 mins to 24 hours after study drug administration)
- Number of Patients With an Incidence of Nausea(30 mins to 24 hours after drug administration)
- Maximum Severity of Nausea(30 mins to 24 hours after study drug administration)
- Evolution Score of Nausea (0-180 Mins)(0-180 minutes after study drug administration)
研究者
研究点 (8)
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