NCT01507194已完成2 期
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared With a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting After Failed Prophylaxis With an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Accenture
- 入组人数
- 131
- 试验地点
- 7
- 主要终点
- Complete Response
研究概览
简要总结
This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female post-operative surgical subjects between the ages of 18-75 years.
- •Female subject is of non-childbearing potential or of child-bearing potential and agrees to use specified contraception methods.
- •Has 3 or more of the following independent risk factors for PONV: female gender; non-smoker; history of PONV or motion sickness; or planned post- operative opioids.
- •Has received one dose of ondansetron as part of a PONV prophylaxis regimen for the surgical procedure.
- •Has received general anesthesia.
- •Meets ASA Physical Status Classification of 1 or 2 without an "E" modifier preoperatively on the day of surgery and has hematology and blood chemistry values within acceptable limits for surgery.
- •Is capable of giving written informed consent.
- •Experiences breakthrough PONV defined as: post-operative nausea of ≥ 7 on the Nausea Numeric Rating Scale; nausea resulting in a subject request for an anti-emetic; or an episode of emesis or retching.
排除标准
- •A history of HIV.
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
- •An ALT or AST >2.5 x ULN at Screening.
- •Pregnant or lactating females.
- •The subject is scheduled to undergo a laparoscopic biopsy only.
- •The subject has a history of or is scheduled to undergo cardiac/cardiothoracic surgery.
- •The subject is scheduled to receive neuraxial anesthesia(e.g., epidural, spinal, or caudal anesthesia)or total IV anesthesia.
- •The subject is scheduled to receive propofol for maintenance of anesthesia (propofol as an induction agent is allowed).
- •The subject is scheduled to receive an NK1 inhibitor (aprepitant/fosaprepitant) as part of a PONV prophylaxis regimen for the surgical procedure.
- •The subject is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric tube, or a nasogastric or oral gastric tube during the post-operative period. A single pass at the beginning or at the end of the procedure, and intraoperative gastric suctioning of air, will be permitted.
- •The subject received an investigational drug within 30 days or was scheduled to receive any investigational drug in addition to vestipitant during the study period.
- •The subject has persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to, gastric outlet obstruction, hypercalcemia, active peptic ulcer, increased intracranial pressure, chemotherapy, or brain metastases.
- •The subject received radiation therapy to the abdomen or the pelvis within 7 days prior to receiving study medications and/or received radiation therapy to the abdomen or the pelvis in the evaluation period.
- •The subject has a history of wound dehiscence.
- •The subject has a history of any other illness which might pose an unacceptable risk by administering study medication.
- •The subject has any current or past medical condition (e.g., vagotomy) and/or required medication to treat a condition that could affect the evaluation of the study.
- •The subject has a known contraindication or hypersensitivity to ondansetron or ondansetron injection, any scheduled anaesthetic or analgesic agents, vestipitant or any component of the vestipitant formulation including Captisol.
- •The subject received medication with known or potential antiemetic activity after the induction of anaesthesia (during the intraoperative or post- operative period) other than the planned Study Treatment.
- •Current or planned use of strong or moderate inhibitors of CYP3A within 7 days or inducers of CYP3A within 14 days prior to study medication administration.
- •The subject is unwilling or unable to follow the procedures outlined in the protocol.
- •The subject is mentally or legally incapacitated.
研究组 & 干预措施
Ondansetron 4 mg
Active Comparator
干预措施: Ondansetron (Drug)
Vestipitant 6 mg
Experimental
干预措施: Vestipitant (Drug)
Vestipitant 12 mg
Experimental
干预措施: Vestipitant (Drug)
Vestipitant 18 mg
Experimental
干预措施: Vestipitant (Drug)
Vestipitant 24 mg
Experimental
干预措施: Vestipitant (Drug)
Vestipitant 36 mg
Experimental
干预措施: Vestipitant (Drug)
结局指标
主要结局
Complete Response
时间窗: 10 min. after infusion start through 24 hrs. or discharge
No emesis and no further rescue medication
次要结局
- Nausea Numeric Rating Scale (NNRS)(Pre-dose; 5, 10, 15 min. post-dose; q 15 min. through 2 hrs. post-dose; q 2 hrs. through 24 hrs. post-dose; and 5 days post-dose)
- No Emesis/Vomiting(Pre-dose; continuous through 24 hrs. post-dose; and 5 days post-dose)
研究者
研究点 (7)
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