Phase 2
Completed N=5
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
Source: ClinicalTrials.gov NCT01378988 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Area Under the Plasma Concentration-time Curve (AUC0-∞) — 4639.17; 14203.544 picogram*hour per millilitre
Summary
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC0-∞) |
4639.17; 14203.544 | — |
| PRIMARY Observed Peak Plasma Concentration (Cmax) |
4499.925; 11737.387 | — |
| PRIMARY Steady State Concentration (Css) |
752.298; 2303.277 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) |
1.958; 2.260 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) |
0.083; 0.283 | — |
| PRIMARY Weight-Adjusted Plasma Clearance (CLw) |
1.292; 0.617 | — |
| PRIMARY Plasma Clearance (CL) |
12.192; 5.836 | — |
| PRIMARY Volume of Distribution (Vd) |
31.845; 15.780 | — |
| PRIMARY Weight-Adjusted Volume of Distribution (Vdw) |
3.343; 1.590 | — |
| PRIMARY Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score |
1.575; 3.220 | — |
| PRIMARY Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period |
3.6; 5.8 | — |
| PRIMARY Number of Subjects Who Received Rescue Medication for Sedation and Analgesic |
1; 1; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is 12 months to 90 U/L at the time of screening.
- Subjects who have hypotension, based on repeat assessments within 15 minutes preceding the start of study drug, defined as: Systolic blood pressure (SBP) <70 mmHg.
- Pre-existing bradycardia based on repeated assessments within 15 minutes preceding the start of study drug, defined as: Heart rate (HR) <70 bpm.
- Subject who have acute thermal burns involving more than 15 percent total body surface area.
- Subjects who have a known allergy to dexmedetomidine, midazolam or fentanyl.
- Subject who has received dexmedetomidine within 15 hours prior to the start of study drug.
- Subjects with a life expectancy that is <72 hours.
- Subjects that are expected to have hemodialysis (continuous hemofiltration), peritoneal dialysis or extracorporeal membrane oxygenation (ECMO) treatments within 48 hours prior to the start of study drug or during the duration of the study.
- Subjects who have been treated with α-2 agonists/antagonists within 2 weeks.
- Subjects with a spinal cord injury above T5 (5th Thoracic Vertebra).
- Subjects who have received another investigational drug as part of an investigational drug study within the past 30 days.
- Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of this clinical study.
Data sourced from ClinicalTrials.gov (NCT01378988). 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. Informational only — not medical advice.