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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cessatech A/S

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

24 May 2024 → 9 May 2025

Decision date (initial)

2023-10-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the safety and tolerability of CT001 in pediatric participants with moderate to severe pain in an acute care setting.
To evaluate the analgesic effect of CT001 in pediatric participants with moderate to severe pain in an acute care setting.

Secondary objectives 4

1. To assess medication errors in pediatric participants with moderate to severe pain in an acute care setting.
2. To evaluate additional analgesic effect of CT001 in pediatric participants with moderate to severe pain in an acute care setting.
3. To evaluate the need of supplemental analgesics.
4. To evaluate feasibility of CT001 in pediatric participants with moderate to severe pain in an acute care setting.

Conditions and MedDRA coding

Pain

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-001739-PIP02-16

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Pediatric participant, age 1 year to 17 years.
2. Attending an Emergency Department (ED) following an injury.
3. Acute pain of moderate or severe intensity (corresponding to 5 or above on an age-appropriate pain scale (0-10 NRS, Wong-Baker FACES scale and FLACC pain scale)
4. Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

Exclusion criteria 16

1. Critical, life- or limb-threatening condition requiring immediate management.
2. Open fractures.
3. Participants with chronic pain.
4. Participants requiring oxygen therapy.
5. Clinically evident respiratory depression.
6. Clinically evident cardiovascular instability (e.g. pathological arrhythmia).
7. Known liver damage.
8. Known significant renal impairment.
9. Presence of other acute clinical or medical condition that may, in the opinion of the investigator, put the potential subject at risk when participating in the study, impact the participant’s ability to participate in the study, or have impact on the study results, including being subject to head injury and / or altered consciousness.
10. Known pregnancy or breastfeeding females.
11. Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
12. Abnormal nasal cavity or nasal obstruction.
13. Known or suspected allergy to ketamine or sufentanil.
14. Has received treatment with sufentanil and/or ketamine during the last 72 hours.
15. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device in the 4 weeks prior to signing the informed consent/assent for this trial.
16. Previous enrolment in the present study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Analgesic efficacy will be assessed as changes in pain intensity from baseline using age relevant scoring instruments (FLACC score for ages ≥ 1 year to < 5 years, the Wong-Baker faces scale from ages ≥ 5 years to < 9 years, and the 0-10 Numerical Rating Scale (NRS) from ages 9 and above).

Secondary endpoints 5

1. Maximum change in pain intensity within 30 min post IMP administration.
2. Number and proportion of participants that achieve a 30% reduction in pain intensity within 30 min post IMP.
3. Change in pain intensity at 10, 15, 20, 30, 45 and 60 min post IMP.
4. Derived variables such as area under curve (AUC), peak change in pain intensity, and duration of effect will be calculated from the recorded pain assessments.
5. Number of children receiving additional analgesics, as assessed by timepoint.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cessatech A/S

Sponsor organisation

Cessatech A/S

Address

Kanonbaadsvej 2

City

Copenhagen K

Postcode

1437

Country

Denmark

Scientific contact point

Organisation

Cessatech A/S

Contact name

Clinical Development Department

Public contact point

Organisation

Cessatech A/S

Contact name

Clinical Development Department

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications