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Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures

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ClinicalTrials.gov Identifier: NCT04897750
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Cessatech A/S

Tracking Information
First Submitted Date  ICMJE May 14, 2021
First Posted Date  ICMJE May 21, 2021
Last Update Posted Date April 27, 2022
Actual Study Start Date  ICMJE August 19, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2021)
  • Total absorption over time [ Time Frame: 0 - 120 minutes ]
    Area under the concentration vs time curve
  • Maximum absorption [ Time Frame: 0 - 120 minutes ]
    Peak concentration (Cmax)
  • Distribution [ Time Frame: 120 - 240 minutes ]
    Volumen of distribution (Vd)
  • Elimination [ Time Frame: 120 - 240 minutes ]
    Half life (T½)
  • Elimination [ Time Frame: 120 - 240 minutes ]
    Clearance,
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • Total absorption over time [ Time Frame: 0 - 120 minutes ]
    Area under the concentration vs time curve
  • Absorption [ Time Frame: 120 - 240 minutes ]
    Peak concentration (Cmax)
  • Absorption [ Time Frame: 120 - 240 minutes ]
    Volumen of distribution (Vd)
  • Elimination [ Time Frame: 120 - 240 minutes ]
    Half life (T½)
  • Elimination [ Time Frame: 120 - 240 minutes ]
    Clearance,
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2021)
  • Analgetic effect [ Time Frame: 0 - 1 hour ]
    pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter
  • Sedation [ Time Frame: 0 - 1 hour ]
    Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score
  • Feasibility, (Acceptance of intranasal administration) [ Time Frame: 0- 4 hours ]
    Acceptance of the intranasal route of administration by the child, assessed by the child or legally acceptable representative or health care provider.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
Official Title  ICMJE Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Analgesia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Active
a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia.
Intervention: Combination Product: CT001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 19, 2021)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Paediatric participants, age 1-17 years at the day of the surgical procedure
  • Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
  • ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
  • Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
  • Needs premedication before induction of anaesthesia as determined by investigator
  • Informed consent by the legally acceptable representative(s)
  • The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
  • A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.

Exclusion Criteria:

  • Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
  • Mental retardation
  • Abnormal nasal cavity or nasal obstruction
  • Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
  • Medical history including substance or alcohol abuse
  • Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
  • Has planned perioperative administration of sufentanil and/or ketamine
  • Has or is suspected of having a family or personal history of malignant hyperthermia
  • Has or is suspected of having allergies to ketamine or sufentanil
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steen Henneberg, MD, P.HD +45 25784942 steen.henneberg@cessatech.com
Contact: Jes Trygved +45 93872309 jes.trygved@cessatech.com
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04897750
Other Study ID Numbers  ICMJE PDC 01-0206
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cessatech A/S
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Cessatech A/S
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Volker Classen, MD Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital
PRS Account Cessatech A/S
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP