Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit

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NCT02757625

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Study Location
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510, Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
ICU Sedation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. 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.

2. Subjects aged ≥45 weeks CGA to <17 years old at time of consent. No restriction on sex of subject.

3. [Elective surgical cases] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis.

4. [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.

5. [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.

6. If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. 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.


2. Subjects with 2nd or 3rd degree heart block during the tests at the screening visit
(excluding subjects using a pacemaker).


3. 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


4. Subject of bradycardia (≤10th centile of heart rate for healthy children) during the
physical examination at screening period.


5. Subjects with ALT ≥100 U/L during the laboratory tests at the screening visit.


6. 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.


7. Subjects who may need a sedative or analgesic (including narcotics) other than
dexmedetomidine, midazolam or fentanyl during treatment with the investigational
product.


8. Subjects who have acute febrile illness [with a temperature (core or tympanic) ≥
38.0°Centigrade] at the screening visit.


9. 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.


10. Subjects who received dexmedetomidine within 48 hours before baseline.


11. 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.


12. 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).


13. 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.

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ICU SedationStudy of DA-9501 In Pediatric Subjects In The Intensive Care Unit
NCT02757625
  1. Asahikawa, Hokkaido
  2. Kobe, Hyogo
  3. Zentsuji, Kagawa
  4. Izumi, Osaka
  5. Takatsuki, Osaka
  6. Shimotsuke, Tochigi
  7. Bunkyo-ku, Tokyo
  8. Fuchu, Tokyo
  9. Kyoto,
  10. Okayama,
  11. Osaka,
  12. Shizuoka,
ALL GENDERS
45 Weeks+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ICU Sedation
Intervention  ICMJE Drug: Dexmedetomidine hydrochloride
  • 45 weeks CGA to < 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state
  • 6 years old to < 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state
Study Arms  ICMJE Experimental: DA-9501
A single vial contains an injection solution with 2 mL of dexmedetomidine hydrochloride solution (100 µg/mL as dexmedetomidine) dissolved in physiological saline
Intervention: Drug: Dexmedetomidine hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2017)		63
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2016)		60
Actual Study Completion Date  ICMJE May 24, 2017
Actual Primary Completion Date May 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. Subjects aged ?45 weeks CGA to <17 years old at time of consent. No restriction on sex of subject.
  3. [Elective surgical cases] Subjects classified as American Society of Anesthesiologists (ASA) (ASA physical status classification) Class I to III by preoperative diagnosis.
  4. [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.
  5. [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.
  6. If a subject is a female of childbearing potential, she should not be pregnant or possibly pregnant, or lactating.

Exclusion Criteria:

  1. 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.
  2. Subjects with 2nd or 3rd degree heart block during the tests at the screening visit (excluding subjects using a pacemaker).

  3. 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
  4. Subject of bradycardia (?10th centile of heart rate for healthy children) during the physical examination at screening period.
  5. Subjects with ALT ?100 U/L during the laboratory tests at the screening visit.
  6. 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.
  7. Subjects who may need a sedative or analgesic (including narcotics) other than dexmedetomidine, midazolam or fentanyl during treatment with the investigational product.
  8. Subjects who have acute febrile illness [with a temperature (core or tympanic) ? 38.0°Centigrade] at the screening visit.
  9. 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.
  10. Subjects who received dexmedetomidine within 48 hours before baseline.
  11. 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.
  12. 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).
  13. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Weeks to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757625
Other Study ID Numbers  ICMJE C0801017
ZIN-DEX-1506 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Maruishi Pharmaceutical
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP