A Single Arm, Open Label Study of the Safety, Efficacy, and Pharmacokinetics of SPRIX (Intranasal Ketorolac Tromethamine) in 0 to 11 Year-Old Patients Undergoing Open Surgical Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Egalet Ltd
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.
详细描述
Evaluate the pharmacokinetics and safety of postoperative administration of SPRIX in pediatric patients (ages 0-11) undergoing open surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ages 0 to 11 years.
- •Undergoing an open surgical procedure expected to result in at least moderate pain based on an age appropriate scale.
- •Body mass index (BMI) ≤ 95th percentile of age.
- •Surgical procedures that would allow the subject to likely remain in the hospital until the morning of post-operative day 3 (to complete PK sample collection).
- •With parental assistance, willing and able to complete the study procedures and pain scales and to communicate meaningfully with the study personnel.
- •In generally good health and capable of undergoing surgery.
- •Females at risk of pregnancy were to use an acceptable form of birth control and have a negative serum or urine pregnancy test (although it is anticipated that all 0-11 year old subjects will be pre-menarchal).
- •Willing to refrain from use of non-study analgesics for the duration of the study, from the day of surgery up to post-operative Day
- •Assents to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the IRB.
排除标准
- •Surgical procedure performed exclusively by laparoscopy.
- •Known allergy or sensitivity to ketorolac, ethylene diamine tetraacetic acid (EDTA).
- •Prior nasal-septal injury or surgery.
- •History of peptic ulcer, gastro-esophageal reflux, or gastrointestinal bleeding.
- •History of advanced renal impairment or a risk for renal failure due to volume depletion.
- •Clinically significant (in the Investigator's opinion) laboratory test value outside the normal range.
- •Use of either (a.) oxycodone at a dose of 30 mg/day or more or (b.) an equivalent dose of another opioid analgesic for a total of more than half of the days during the preceding month.
- •The patient requires regular use (daily use in at least 25 days per month) in the 3 months prior to surgery of NSAID's , COX2 inhibitors, tramadol, or acetaminophen at daily dose of more than 2 g for the management of pain.
- •Contraindication to the use of morphine, general anesthetics, bupivacaine, ropivacaine, lidocaine, other local anesthetics, muscle relaxants, hydrocodone, ondansetron, or acetaminophen (e.g., significant history of allergic reactions or intolerance to these or related substances).
- •Known bleeding diathesis or other disorder or current use of agents affecting coagulation. Deep venous thrombosis prophylaxis of the surgeon's choice is permitted postoperatively.
- •Current use of Central Nervous System (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, or Selective Serotonin Reuptake Inhibitors (SSRIs) for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of lorazepam and other sleep medications, except those containing analgesic properties, are permitted.
- •Current diabetes mellitus and HbA1C > 9.5 or a history of prolonged uncontrolled diabetes.
- •Use of an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days.
- •Any medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including active infection.
- •History of drug, prescription medicine, or alcohol abuse that would interfere with the subject's safety or the assessments of efficacy in this trial, in the judgement of the investigator.
- •History of nasal mucosal damage or active seasonal allergies, nasal congestion or upper respiratory tract infection sufficient to interfere with intranasal drug delivery.
- •Administration of an investigational product within 3 months prior to the first dose of study drug, or scheduled to receive an investigational product, while participating in the study.
- •Use of Toradol (ketorolac tromethamine) in any formulation within the past 30 days prior to study entry and throughout study participation.
研究组 & 干预措施
SPRIX(intranasal ketorolac tromethamine)
Based on subject weight
干预措施: SPRIX(intranasal ketorolac tromethamine) (Drug)
结局指标
主要结局
Cmax
时间窗: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs
Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.
tmax
时间窗: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs
Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.
Ctrough
时间窗: Pre-dose, .25, .5, .75, 1, 2, 4, 6 hrs after the 1st dose then prior to each ensuing dose until morning of post-operative Day 2. After a single dose on morning of post-operative Day 2 PK samples will be collected @ 1, 2, 4, 6, 8, 12, & 24 hrs
Blood samples will be collected for PK assessment pre-dose, at .25, .5, .75, 1, 2, and 4 hours after the first dose, at 6 hours immediately before the 2nd dose and before each of the next doses up to the dose to be administered on the morning of post operative Day 2. Blood samples will then be collected for PK assessment at 1, 2, 4, 6, 8, 12, and 24 hours after receiving the morning dose on Day 2.
次要结局
未报告次要终点