EUCTR2005-005855-16-CZ进行中（未招募）不适用
A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 462 人开始时间: 2006年4月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 462
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
- Female
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. is 18 years of age or older
- •2. has all four Apfel risk factors:
- •female gender
- •a history of PONV and/or motion sickness
- •a non-smoker: defined for this study as one who has not smoked or used (e.g., chewing) tobacco (including a nicotine patch or other nicotine-withdrawal formulation) for at least the previous 6 months.
- •anticipated to receive opioids postoperatively
- •3. is scheduled to undergo one of the following surgical procedures: breast surgery, orthopaedic shoulder surgery, or thyroid surgery. The following laparoscopic or laparotomic procedures are also permitted: cholecystectomy, hysterectomy, or other gynaecologic surgery
- •4. surgery must be anticipated to involve general anesthesia of at least one hour duration.
- •5. scheduled to receive general inhalation anesthesia with an anesthetic regimen as described in the protocol under Section 4.2., Anesthetic and Analgesic Regimen”.
- •6. meets the American Society of Anesthesiologists (ASA) Physical Status Classification of P1 or P2, preoperatively, on the day of surgery.
- •7. willing and expected to be able to complete daily components of the subject diary preoperatively on the day of surgery and until the end of the 48 hour assessment period, and return to the investigational site at the post-op Day 6-14 final study visit.
- •8. understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
- •9. women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
- •a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as one year without menses). These subjects do not need to follow the birth control practices outlined in this protocol.
- •b. child-bearing potential: has a negative serum pregnancy test result or a negative urine dipstick pregnancy test at baseline (within 24 hours prior to investigational product administration) and agrees to one of the following:
- •male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
- •oral contraceptives (either combined or progestogen only) which must be combined with double-barrier method of contraception consisting of spermicide with either condom or diaphragm
- •double-barrier method of contraception consisting of spermicide with either condom or diaphragm
- •intra-uterine device (IUD) with a documented failure rate of less than 1% per year
- •complete abstinence from intercourse for two weeks prior to exposure to the investigational product throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days after exposure to the investigational product, equivalent to five half-lives)
- •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
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. is pregnant or lactating
- •2. is scheduled to receive propofol for maintenance of anesthesia
- •3. has received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug in addition to GW679769 during the study period
- •4. has persistent or recurrent nausea and/or vomiting due to other etiologies
- •5. is taking greater than 10 mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than three consecutive days prior to entry into the study.
- •6. has a medical condition (e.g., vagotomy) or is receiving medication that could confound the results of this study
- •7. is anticipated to require a nasogastric or oral-gastric tube with intermittent or continuous suctioning post-operatively
- •8. has baseline ALT/AST >1.5x the upper limit of normal, unless due to the condition for which the subject is undergoing surgery, in which case the acceptable limit is 3x the upper limit of normal
- •9. has baseline bilirubin >1.5x the upper limit of normal, unless due to the condition for which the subject is undergoing surgery, in which case the acceptable limit is 3x the upper limit of normal
- •10. has a known hypersensitivity to ondansetron, another 5-HT3 receptor antagonist, any component of GW679769, or any of the scheduled anesthetic or analgesic agents
- •11. is scheduled to receive antiemetics not included in the study dosing scheme, during the evaluation period, or has received medication with potential antiemetic activity in the 24 hour period, (or as specified below), prior to surgery. This includes, but is not limited to:
- •5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonosetron is not permitted for seven days prior to the study.
- •benzamide/benzamide derivatives (e.g., metoclopramide, alizapride)
- •phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine)
- •butyrophenones (e.g., haloperidol, droperidol)
- •corticosteroids (e.g., dexamethasone, methylprednisolone – with the exception of topical steroids for skin and/or ocular disorders and inhaled steroids for respiratory disorders)
- •scopolamine
- •antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine); however, diphenhydramine for pruritis is allowed
- •domperidone
- •cannabinoids
- •12. has taken/received strong or moderate inhibitors of CYP3A4 and/or CYP3A5 within the following time frames prior to administration of the investigational product, or during the 48 hour assessment period:
- •2 days: clarithromycin, diltiazem, erythromycin, ketoconazole, verapamil
- •14 days: fluconazole, itraconazole
- •13. has taken /received inducers of CYP3A4 and/or CYP3A5 within 14 days prior to the administration of the investigational product, or during the 48 hour assessment period, including: carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St. John’s wort, and troglitazone
- •14. is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of GW679769 is a potential inhibitor of CYP2C8.
- •15. In France, a subject is neither affiliated with nor a beneficiary of a social security category.
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