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

Phase 2

Recruiting

• Conditions: Pain
• Interventions: Drug: CT001

• Registration Number: NCT06364072
• Lead Sponsor: Cessatech A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-15
• Study Start: 2024-05-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-05-25
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT001	CT001	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To assess medication errors	0 min	Number of medication errors

Trial Locations

Locations (7)

Hospital General Universitario Dr. Balmis; 🇪🇸 Alicante, 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, Spain

Birmingham Women's and Children's NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Royal London Hospital; 🇬🇧 London, United Kingdom

Sheffield Children's Hospital; 🇬🇧 Sheffield, United Kingdom