Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364072
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-02
Brief Title:
Safety Tolerability Analgesic Effect and Feasibility of Intranasal CT001 in Pediatric Patients
Sponsor:
Cessatech AS
Organization:
Cessatech AS
Study Overview
Official Title:
Open-label Prospective Study to Assess the Safety Tolerability Analgesic Effect and Feasibility of Intranasal SufentanilKetamine in Pediatric Patients With Moderate or Severe Pain in an Acute Care Setting
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study aims to investigate the safety tolerability analgesic efficacy and feasibility of intranasal sufentanilketamine CT001 in pediatric participants attending an acute care ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504023-63-00 | CTIS | None | None |