Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364072
• Other study ID #: PDC 01-0202
• Secondary ID: 2023-504023-63-0
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 27, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: May 2024
• Source: Cessatech A/S
• Contact: Malene C Christensen
• Phone: +45 61715350
• Email: malene.cording[@]cessatech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 20, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Pediatric participant, age 1 year to 17 years

• Attending an Emergency Department following an injury

• Acute pain of moderate or severe intensity

• Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion Criteria:

• Participant showing abnormal nasal cavity/airway such as:

1. major septal deviation

2. evidence of previous nasal disease or surgery

3. current significant nasal congestion due to common cold

• Has received treatment with sufentanil and/or ketamine during the last 72 hours

• Known or suspected allergy to ketamine or sufentanil

• Critical, life- or limb-threatening condition requiring immediate management

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• CT001
Intranasal

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Barcelona
Spain	Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -	Madrid
Spain	Complejo Hospitalario Universitario de Santiago (CHUS)	Santiago De Compostela
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham
United Kingdom	Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cessatech A/S

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability	The number and proportion of participants with Adverse Events Number of Adverse Events, graded by severity, and number of Serious Adverse Events.	Through study completion; up to 7 days
Primary	To evaluate the analgesic effect	Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below)	15 and 30 min post Investigational Medicinal Product administration
Secondary	To assess medication errors	Number of medication errors	0 min