Phase 3
N=63
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
ICU Sedation
Bottom Line
View on ClinicalTrials.gov: NCT02757625 ↗Enrolled (actual)
63
Serious AEs
1.6%
Results posted
Dec 2018
Primary outcome: Primary: Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug — 78.6; 66.7; 78.9; 91.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine hydrochloride (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug |
78.6; 66.7; 78.9; 91.7; 77.8 | — |
| SECONDARY Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug |
85.7; 100.0; 94.7; 66.7; 88.9 | — |
| SECONDARY Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug |
0.882; 3.188; 2.469; 1.960; 2.401 | — |
| SECONDARY Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug |
0.135; 0.353; 0.142; 0.100; 0.228 | — |
| SECONDARY Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug |
91.70; 97.50; 81.74; 86.84 | — |
| SECONDARY Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug |
15.00; 5.00; 3.78; 7.16 | — |
| SECONDARY Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug |
7.95; 3.89; 3.52; 2.96; 4.50 | — |
| SECONDARY Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug |
54.08; 60.97; 50.54; 62.25; 56.54 | — |
| SECONDARY Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
100.0; 100.0; 100.0 | — |
| SECONDARY 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 |
100.0; 100.0; 100.0 | — |
| SECONDARY Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
— | — |
| SECONDARY Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
— | — |
| SECONDARY Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
— | — |
| SECONDARY Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
— | — |
| SECONDARY Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
0.81; 0.92; 0.84 | — |
| SECONDARY Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation |
75.00; 100.00; 83.33 | — |
| SECONDARY Duration of Maintenance of Target Sedation Level After Extubation |
11.68; 7.73; 7.60; 6.73; 8.42 | — |
| SECONDARY Percentage of Maintenance Duration of Target Sedation Level After Extubation |
69.99; 53.93; 54.45; 55.82; 58.19 | — |
| SECONDARY Total Amount of Rescue Sedative Taken After Extubation |
0.537; 0.719; 5.994; 1.701 | — |
| SECONDARY Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation |
0.109; 0.072; 0.370; 0.146 | — |
| SECONDARY Total Amount of Rescue Analgesic Taken After Extubation |
42.90; 42.90 | — |
| SECONDARY Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation |
3.00; 3.00 | — |
| SECONDARY Median Time to Conclusion of Mechanical Ventilation |
9.5; 6.0; 4.1; 4.5; 6.0 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02757625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.