SMR-3965
Research type
Research Study
Full title
Open-label, prospective study to assess the safety, tolerability, analgesic effect and feasibility of IN SUF/KET in pediatric patients with moderate or severe pain, in an acute care setting.
IRAS ID
1006944
Contact name
Amanda Knock
Contact email
Sponsor organisation
Cessatech A/S
Clinicaltrials.gov Identifier
Research summary
Research Summary
This is a phase 3 multi-national (UK and Spain) multi-centre (approx. 6 sites) study where participants aged 1 to 17 years will be treated with an nasal spray containing CT1001 (sufentanil and ketamine) for moderate or severe pain from a physical wound or injury. CT1001 relieves pain, is calming and induces sleepiness.
Despite the many pain-relieving products available for adult patients, few of these have been developed for children and there is a significant unmet medical need for treatment of acute pain in this population.
The nasal spray formulation of CT1001 has several advantages over other pain management delivery methods including needle free administration, ease of administration and rapid onset of effects.
The purpose of this study is to investigate the safety and efficacy of CT1001 in paediatric patients with moderate or severe pain. Approximately 150 participants will be included in this study who present at the emergency department of the hospital. They will be reviewed for eligibility into the study, their vital signs reviewed, and pain assessed. Each participant will receive one or two doses of nasal CT1001 with 10 to 15 minutes in between. After each dose pain will be assessed using pain scales. Participants or parents / legal guardians will receive a follow-up phone call 2 to 7 days later to check on their health.Summary of Results
Protocol no: PDC 01-0202
EU Trial no: 2023-504023-63-00
Clinicaltrials.gov identifier: NCT06364072
2 Who sponsored this study?
Cessatech A/S
info@cessatech.com
3 Where was this study done?
This study took place in Spain and the United Kingdom (UK)
4 When was this study done?
The trial started in May 2024 and ended in May 2025
5 Why was this research needed?
Despite the many pain-relieving products available for adult patients, few of these have been developed for children and there is a significant unmet medical need for the treatment of moderate to severe pain in this population. The nasal spray formulation of CT001 has several advantages over other pain management delivery methods including needle free administration, ease of administration and rapid onset of effects. Hence, the purpose of this study is to investigate the safety and efficacy of CT001 in paediatric patients with moderate or severe pain.
6 What were the main questions of this study?
The purpose of this study was to see how well the test medicine CT001 works and how safe it is in children who have moderate to severe pain following an injury.
7 Who participated in this study?
This study included 155 children, males and females, aged between 1 and 17 years old, who were in the emergency department and needed pain relief for moderate to severe pain. In Spain, 83 children were enrolled and in the UK 72 children were enrolled in this study.
8 What treatment did the participants receive?
The test medicine is called CT001. It contains the active ingredients sufentanil and ketamine. The medicine was given as a nasal spray at a dose of 0.5 mcg/kg sufentanil and 0.5 mg/kg ketamine. CT001 is not yet approved by authorities to treat pain in children.
9 What medical problems (adverse reactions) did the participants have?
No serious adverse reactions were reported for this study. 77 out of 155 children had reported reactions to CT001. All reactions to the test medicine were mild or moderate and the most common were:Vomiting 16.13% (25 children)
Dizziness 14.19% (22 children)
Nausea 9.03% (14 children)
Symptoms related to the taste of the study medicine 12.26% (19 children)
10 What happened during the study?
Researchers gave the test medicine, CT001, to patients with moderate to severe pain following an injury to find out how well the medicine works and how safe it is. All the children in the study were given the test medicine CT001. Both the children and the doctors knew that the children were given CT001. The children were followed up, up to 6 days after they were given the test medicine to check for any reactions to CT001.
11 What were the results of the study?
Before receiving the study medicine CT001, each child’s pain resulting from their injury (the reason for their hospital visit) was ranked using an age-appropriate pain scale (baseline). All scales ranged from 0 to 10, where 0 meant no pain and 10 meant the worst possible pain. After receiving CT001, the children’s pain was ranked again at several different time points to see how it changed over time. A score of 4 or below relates to no pain (i.e. a score of 0) or mild to moderate pain.
Pain relief in all children
At 15 minutes after receiving CT001, 54% (82 children) had a pain score of 4 or below. At 30 minutes, this number increased to 88% (134 children).
Pain relief continued for at least 60 minutes, with the average pain score reduced by almost 86% compared to baseline.
Pain relief by age groupChildren aged 1 to under 5 years:
At 15 minutes, 74% (17 children) had a pain score of 4 or below.
At 30 minutes, 100% (all 23 children) had pain scores of 4 or below.
Children aged 5 to under 9 years:
At 15 minutes, 58% (21 children) had pain scores of 4 or below.
At 30 minutes, 92% (33 children) had pain scores of 4 or below.
Children aged 9 to under 18 years:
At 15 minutes, 47% (44 children) had pain scores of 4 or below.
At 30 minutes, 84% (78 children) had pain scores of 4 or below.
These results show that CT001 was effective in treating pain across all age groups.
The safety data did not show any safety concerns and was well tolerated across all age groups.
12 How has this study helped patients and researchers?
Findings from this study will be used to seek approval for using CT001 for treatment of moderate to severe pain in children ages 1 to less than 18 years.
13 Are there plans for further studies?
No further clinical studies with CT001 are planned at the current time.
14 Where can I find more information about this study?
To learn more about this study, you can find detailed information on this website https://clinicaltrials.gov/study/NCT06364072REC name
East of Scotland Research Ethics Service REC 2
REC reference
23/ES/0027
Date of REC Opinion
21 Sep 2023
REC opinion
Further Information Favourable Opinion