At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 155 enrolled
Drug / intervention
CT001drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Prospective Study to Assess the Safety, Tolerability, Analgesic Effect and Feasibility of Intranasal Sufentanil/Ketamine in Pediatric Patients With Moderate or Severe Pain, in an Acute Care Setting
In Brief
A Phase 3 clinical trial evaluating CT001 for Pain. Completed, enrolled 155 participants across 7 sites in 2 countries.
Detailed Summary
The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesSpain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20252026
First PostedApr 2024
Enrollment StartMay 2024
Primary CompletionMay 2025
TodayJul 2026
First PostedApr 15, 2024
Enrollment StartMay 27, 2024
Primary CompletionMay 9, 2025
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.2 years ago
Interventions
CT001drug
Intranasal