Trials / Completed
CompletedNCT06364072
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Cessatech A/S · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CT001 | Intranasal |
Timeline
- Start date
- 2024-05-27
- Primary completion
- 2025-05-09
- Completion
- 2025-05-09
- First posted
- 2024-04-15
- Last updated
- 2026-02-02
- Results posted
- 2026-02-02
Locations
7 sites across 2 countries: Spain, United Kingdom
Source: ClinicalTrials.gov record NCT06364072. Inclusion in this directory is not an endorsement.