Trials / Completed
CompletedNCT04897750
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Cessatech A/S · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants \>2-6 years and 9 paediatric participants \>6-17 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | CT001 | Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed. |
Timeline
- Start date
- 2021-08-19
- Primary completion
- 2022-05-16
- Completion
- 2022-05-16
- First posted
- 2021-05-21
- Last updated
- 2022-08-18
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04897750. Inclusion in this directory is not an endorsement.