EUCTR2011-006006-27-IT进行中（未招募）1 期
A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics/Pharmacodynamics, Safety, and Tolerability of Aprepitant in Pediatric Patients for the Prevention of Post Operative Nausea and Vomiting. - Pediatric PONV PK/PD Study
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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
入选标准
- •1. Patient is birth (at least 37 weeks gestation and =3 kg of weight) to 17 years of age at the time of randomization.
- •2. Patient is scheduled to receive general anesthesia AND:
- •Patients must have at least one of the following risk factors for PONV (in
- •addition to receiving general anesthesia):
- •o Surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy –ORo Operative procedure associated with PONV: intraoperative use or anticipated opioid administration within the first 24 following surgery.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 260
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient is undergoing emergency surgery for a life threatening condition.
- •2. Patient is scheduled to receive propofol for maintenance of
- •anesthesia. (Note: propofol is permitted for induction of anesthesia).
- •3. Patient is expected to receive opioid antagonists (e.g., naloxone,
- •naltrexone) or benzodiazepine antagonists (e.g., flumazenil)
- •4. Patient is scheduled to undergo cardiac or neurosurgery.
- •5. Patient has vomited within 24 hours prior to surgery.
- •6. Patient has an active infection (e.g., pneumonia), any uncontrolled
- •disease (e.g., diabetic ketoacidosis, pre-existing gastrointestinal
- •conditions/gastrointestinal obstruction) except for malignancy, or a
- •history of any illness, which, in the opinion of the investigator, might
- •confound the results of the study or pose unwarranted risk in
- •administering study drug/comparator to the patient.
- •7. Patient has a nasogastric or oral gastric tube intra- or postoperatively
- •for suctioning gastric contents (Note: nasogastric or oral
- •gastric tube intra- or post-operatively may ONLY be used for feeding.
- •Patients should be excluded if a nasogastric or oral gastric tube is
- •routinely used for the type of surgery to be performed).
- •8. Patients with a know history of CT prolongation.
- •9. Patient is allergic to aprepitant, ondansetron or any 5-HT3 antagonist.
- •10. Patient is taking the anti-coagulant warfarin.
研究者
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