EUCTR2010-019109-40-BG进行中（未招募）不适用
A multicenter, randomized, observer-blinded, single-dose, placebo-controlled, sequential cohort study of the efficacy and safety of Xen2174 in subjects following bunionectomy surgery
Xenome Ltd0 个研究点目标入组 150 人开始时间: 2010年12月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •Subject is able to read and voluntarily sign the written informed consent document as approved by the Competent Authority, if applicable, and Independent Ethics Committee (IEC), and is given the opportunity to ask questions regarding the study prior to signing the informed consent and performance of any study-specific procedures.
- •Subject must require primary unilateral first metatarsal bunionectomy surgery (including osteotomy) to correct hallux valgus
- •Subject must be male or female 18-65 years of age.
- •Subject is Class ASA 1 or ASA 2 using the American Society of Anesthesiologists Physical Status Classification System.
- •If female, subject is non-lactating, and is either:
- •1. not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;
- •2. of childbearing potential but is not pregnant as confirmed by negative serum pregnancy test at the time of screening, and is practicing one of the following methods of birth control: oral, transdermal or parenteral contraceptives for 3 months prior to Study Drug administration or double-barrier method. If serum pregnancy test results are inconclusive, then the pre-surgical urine pregnancy test will determine eligibility.
- •Subject must be willing and able to comply with the protocol, and able to score their pain intensity.
- •Subject is in good health as determined by the Investigator on the basis of medical history, physical examination, ECG, and screening laboratory results.
- •Subject must be suitable for intrathecal bolus administration of either Xen2174 in a 5% dextrose solution or a 5% dextrose solution (Placebo), with no anatomical or pathological abnormalities that would compromise intrathecal lumbar injection.
- •Subject is willing and able to remain at the research center for the entire 3-day Treatment Period.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject is pregnant or lactating.
- •Subject has been on an investigational drug within 30 days prior to the initiation of Study Drug.
- •Subject has had prior exposure to Study Drug in a previous clinical trial.
- •Subject has a condition that would contraindicate the use of opioid analgesia, particularly chronic respiratory compromise.
- •Subject is morbidly obese (body mass index = 35 kg/m2 ).
- •Subject has chronic respiratory insufficiency.
- •Subject is on chronic opioid therapy, or is opioid tolerant in the judgment of the Investigator because of routine opioid use.
- •Subject has a known allergy or hypersensitivity to opioids, paracetamol and/or ondansetron.
- •Subject has known bleeding disorder or is taking agents affecting coagulation preoperatively [deep vein thrombosis (DVT) prophylaxis is of the Investigator’s choice postoperatively].
- •Subject has any other condition or factor, such as an intracranial lesion associated with increased intracranial pressure, cognitive impairment or mental illness, which in the opinion of the Investigator might increase the risk to the subject or that precludes the subject’s ability to adhere to the protocol procedures.
- •Subject has a known or suspected history of substance or alcohol abuse within 2 years prior to Screening, or is currently using alcohol, drugs of abuse, or any prescription, or over-the-counter medication, in a manner that the Investigator considers indicative of abuse/dependence.
- •Subject tests positive to drug screens – amphetamines, methamphetamines (including MDMA/3,4-methylenedioxymethamphetamine), barbiturates, benzodiazepines, THC/marijuana, cocaine and its metabolites (e.g., benzoylecgonine), morphine and its related metabolites derived from opium (opiates), opioids, methadone, PCP (phencyclidine/phenylcyclohexylpiperidine), tricyclic antidepressants – that cannot be justified by prescription use.
- •Subject is receiving central nervous system (CNS) drugs for pain, such as a selective serotonin reuptake inhibitor (SSRI), a selective norepinephrine receptor inhibitor (SNRI), monoamine oxidase inhibitor (MAOI), carbamazepine, or tricyclic amine (TCA) compounds within 1-month prior to Check-In.
- •[Note: if subject is on stable dose of SSRIs or SNRIs for 6 weeks prior to Screening and for a diagnosis other than relief of pain, then they may be eligible for participation in the trial, providing stable doses of the medications are maintained postoperatively].
- •Subject has a documented history of seizure, prior head injury resulting in unconsciousness, or has been prescribed anti-seizure medication.
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