NCT02757625已完成3 期
Phase 3, Multi-center, Single-arm, Open-label Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of Da-9501 (Dexmedetomidine Hydrochloride) In Pediatric Subjects In The Intensive Care Unit
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug
研究概览
简要总结
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care unit
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
- 45 Weeks 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects whose consent is obtained in writing prior to the clinical trial from a guardian after a full explanation. For subjects over 7 years old, it is desirable that an informed assent is also obtained from the pediatric subject him/herself when possible.
- •Subjects aged ≥45 weeks CGA to <17 years old at time of consent. No restriction on sex of subject.
- •[Elective surgical cases] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis.
- •[Elective surgical cases] Subjects who require at least 6 hours of respiratory management with intubation under intensive care from immediately after surgery and are anticipated to require sedation.
- •[Medical ICU cases] Subjects who require at least 24 hours of respiratory management with intubation under intensive care and are anticipated to require sedation. For medical ICU cases, sedatives used prior to treatment with the investigational product should be discontinued before the start of treatment with the investigational product.
- •If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.
排除标准
- •Subjects who are judged by investigator or sub-investigator to have a neurological disease that will make sedation assessment difficult, such as:
- •Subjects with brain damage which is expected to increase intracranial pressure due to trauma or central nervous system disease
- •Subjects with cerebral palsy, autism, severe mental retardation, etc.
- •Subjects with paralysis due to continuous administration of a muscle relaxant or due to a spinal injury of class T5 or higher.
- •Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker).
- •Subjects with any of the following low blood pressure levels during the tests at the screening visit:
- •Age ≥ 45 weeks CGA to < 1 year old: Systolic Blood Pressure (SBP) <70 mmHg
- •Age ≥ 1 year old to < 10 years old: SBP < 70 + (2 x age in years) mmHg
- •Age ≥ 10 years old to < 17 years old: SBP < 90 mmHg
- •Subject of bradycardia (≤10th centile of heart rate for healthy children) during the physical examination at screening period.
- •Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit.
- •Subjects in whom dexmedetomidine or other alfa 2 receptor agonists, alfa 2 receptor antagonists and drug that may be used in this study are contraindicated.
- •Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product.
- •Subjects who have acute febrile illness [with a temperature (core or tympanic) ≥ 38.0°Centigrade] at the screening visit.
- •Subjects who received other investigational product within 30 days before baseline or subjects who will participate in other study that uses an investigational product during the study period.
- •Subjects who received dexmedetomidine within 48 hours before baseline.
- •Subjects who, in the opinion of the investigator or sub-investigator, may be at increased risk to the subject due to the conduct of the study or may have a disease or factor which will probably preclude the obtainment of sufficient study data.
- •Subjects for whom, in the opinion of the investigator or sub-investigator, risks involved with administration of dexmedetomidine outweigh its benefits (e.g., >2 doses of vasopressor due to cardiogenic shock).
- •Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Sponsor's employees directly involved in the conduct of the study.
研究组 & 干预措施
DA-9501
Experimental
A single vial contains an injection solution with 2 mL of dexmedetomidine hydrochloride solution (100 µg/mL as dexmedetomidine) dissolved in physiological saline
干预措施: Dexmedetomidine hydrochloride (Drug)
结局指标
主要结局
Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug
时间窗: From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)
Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation \[placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs\], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation \[removal of endotracheal tube\], the target sedation depth was -1 to 0, where higher score indicated more responsive) were reported.
次要结局
- Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug(From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days))
- Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation(After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days))
- Duration of Maintenance of Target Sedation Level After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Percentage of Maintenance Duration of Target Sedation Level After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Total Amount of Rescue Sedative Taken After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Total Amount of Rescue Analgesic Taken After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation(From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days))
- Median Time to Conclusion of Mechanical Ventilation(Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days))
研究者
研究点 (12)
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