Clinical trial

A PHASE 3/4 RANDOMIZED, DOUBLE-BLIND, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF DEXMEDETOMIDINE (DEX) USED WITH PROPOFOL (PRO) AS NEEDED FOR PROCEDURAL SEDATION OF PEDIATRIC SUBJECTS ≥1 MONTH TO <17 YEARS OF AGE UNDERGOING MRI SCANS

Name

C0801039

Description

This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \<17 years of age undergoing MRI scans in the US and Japan.

Trial arms

Trial start

2020-02-18

Estimated PCD

2021-11-02

Trial end

2021-11-30

Status

Completed

Phase

Early phase I

Treatment

dexmedetomidine

dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan

Arms:

dexmedetomidine high dose group, dexmedetomidine low dose group, dexmedetomidine middle dose group

propofol

propofol IV administration will be given if needed to maintain sedation

Arms:

dexmedetomidine high dose group, dexmedetomidine low dose group, dexmedetomidine middle dose group

Size

128

Primary endpoint

Percentage of Participants at the DEX High Dose Versus Low Dose in the Combined Age Cohorts Who Did Not Require Concomitant PRO to Complete MRI

Up to maximum of 3 hours during MRI scan on Day 1

Eligibility criteria

Key Inclusion Criteria: 1. Male or female subject ≥1 month and \<17 years of age. 2. American Society of Anesthesiologists (ASA) Physical Status I, II or III. 3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance. 4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete Key Exclusion Criteria: 1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects. 2. Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts. 3. Planned medical procedure during the MRI scan or post-MRI recovery period. 4. Requires endotracheal intubation or laryngeal mask airway (LMA). 5. Known allergy to eggs, egg products, soybeans or soybean products. 6. SpO2 \<93 % on room air -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 128, 'type': 'ACTUAL'}}

Updated at

2022-11-16

1 organization

2 products

1 indication

Organization

Product

Indication

Product