Clinical Trial Results:
Pharmacokinetic study of intranasal CT001 in children 1-17 years of age undergoing elective surgical procedures
Summary
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EudraCT number |
2021-000137-14 |
Trial protocol |
DK |
Global end of trial date |
13 May 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
10 May 2023
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First version publication date |
10 May 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
PDC-01-0206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04897750 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Cessatech AS
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Sponsor organisation address |
Kanonbådsvej 2, Copenhagen, Denmark, 1437
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Public contact |
CEO, Cessatech A/S, jes.trygved@cessatech.com
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Scientific contact |
CEO, Cessatech A/S, jes.trygved@cessatech.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001739-PIP02-16 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 May 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
13 May 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary objectives:
• To determine the PK profile of CT001 in children 1-2 years undergoing surgical procedures.
• To collect supplemental PK data in children >2-17 years.
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Protection of trial subjects |
None
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Background therapy |
None | ||
Evidence for comparator |
No comparator | ||
Actual start date of recruitment |
19 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 26
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Worldwide total number of subjects |
26
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EEA total number of subjects |
26
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
8
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Children (2-11 years) |
9
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Adolescents (12-17 years) |
9
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
26 subjects were screened for the study at one site in Denmark during the period 19-Aug-2021 until 13-May-2022. Of these 26 subjects screened 25 subjects received IMP. | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
26 | ||||||
Number of subjects completed |
25 | ||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 1 | ||||||
Period 1
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Period 1 title |
Treatment period 1 (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
Not relevant, open study
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Arms
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Arm title
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CT001 | ||||||
Arm description |
Intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, and an additional dose if needed as premedication 10 minutes before placement of a peripheral venous catheter for induction of anaesthesia. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
CT001
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Investigational medicinal product code |
CT001
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Intranasal use
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Dosage and administration details |
Intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, and an additional dose if needed as premedication 10 minutes before placement of a peripheral venous catheter for induction of anaesthesia.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: One patient was withdrawn during screening. |
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Baseline characteristics reporting groups
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Reporting group title |
CT001
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Reporting group description |
Intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, and an additional dose if needed as premedication 10 minutes before placement of a peripheral venous catheter for induction of anaesthesia. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
CT001
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Reporting group description |
Intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, and an additional dose if needed as premedication 10 minutes before placement of a peripheral venous catheter for induction of anaesthesia. |
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End point title |
Cmax Ketamine IN [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
One dosing with a optional second dose if needed
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable |
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No statistical analyses for this end point |
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End point title |
AUC0-last Ketamin IN [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
One dose with a optional second dose if needed.
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable |
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No statistical analyses for this end point |
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End point title |
Cmax Sufentanil IN [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
One dose with a optional second dose if needed.
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable |
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No statistical analyses for this end point |
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End point title |
AUC0-last Sufentanil IN [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
One dose with a optional second dose if needed.
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Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Not applicable |
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No statistical analyses for this end point |
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End point title |
Pain assessment | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Pain intensity assessment before and after placement of PVC
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No statistical analyses for this end point |
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End point title |
Sedation assessment | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Sedation assessment after IMP
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were collected from the first dose until 24 hours after dosing.
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Adverse event reporting additional description |
Adverse events were collected based on study personnel observations during dosing and observation on site and spontaneous reporting from subjects/parents.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||
Dictionary version |
24
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
Events for all subjects who received at least one dose | ||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |