PainPhase 2/3NCT06364072

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

A Phase 2/3 study testing CT001 in people with Pain, run by Cessatech A/S at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year to 17 years
Conditions the study is for: Pain
What is being tested?: CT001
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 155 participants
Where: 7 sitesin 2 countries
Study dates: 27 May 2024to 9 May 2025
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

Participant showing abnormal nasal cavity/airway such as:
major septal deviation
evidence of previous nasal disease or surgery
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

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Spain4 sites

Hospital General Universitario Dr. Balmis
Alicante
Hospital Sant Joan de Deu
Barcelona
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -
Madrid
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela

Other trials in Spain

United Kingdom3 sites

Birmingham Women's and Children's NHS Foundation Trust
Birmingham
Royal London Hospital
London
Sheffield Children's Hospital
Sheffield

Other trials in United Kingdom

About this study

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

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.

Conditions: Pain
Being tested: CT001
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT001Drug
Intranasal

Study groups in NCT06364072
Study group	Role	What they receive
CT001	Experimental	Not described Receives: Drug: CT001

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation
Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation.
Measured: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.
Respiratory Depression
Respiratory depression assessed by respiratory rate.
Measured: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Peripheral Oxygen Saturation
Peripheral oxygen saturation assessed by oxygen saturation rate (%)
Measured: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Cardiovascular Stability
Cardiovascular stability assessed by pulse rate (bpm)
Measured: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Number of Reported Adverse Events
Number of reported adverse events.
Measured: Through study completion; up to 7 days
Number of Adverse Events (AEs) Reported Per Participant
Number of adverse events (AEs) reported per participant.
Measured: Through study completion; up to 7 days
Local Nasal Irritation
The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation.
Measured: 30 and 60 min post IMP administration
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). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).
Measured: At baseline and at 15 and 30 min post first IMP dose

Secondary outcomes (7)

Treatment Satisfaction
Treatment satisfaction as assessed by responses to the question: "How satisfied are you with the study drug that you/your child received? Please think about how it helped their pain, how it was given, any side effects, and how quickly you/your child recovered". Respondents answered using a 5-point Likert scale (very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very satisfied (5)).
Measured: Prior to Emergency Department discharge (day of IMP administration)
Feasibility (Acceptance of Nasal Administration)
Feasibility (i.e. acceptance of nasal administration) was addressed by the healthcare staff asking the participant: "If you were in this situation again and needed pain medication, would you like to receive the nasal spray (relative to an injection, tablet or suppository for the pain)?' If not possible by the participant, the parent/legal guardian assessed nasal acceptability. Answers were "yes, "no", "I don't know".
Measured: Prior to Emergency Department discharge (day of IMP administration)
Medication Errors
Medication errors, defined as any deviation in the IMP administration instructions that resulted in higher or lower dose than planned. Examples may include erroneous priming of the pump, too few/many pumps administered, etc.
Measured: Assessed immediately post IMP administration
Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.
Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).
Measured: 30 min post (first) IMP administration
Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline
Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).
Measured: within 30 min post (first) IMP administration.
Change From Baseline in Pain Intensity
Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).
Measured: at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration.
Number of Children Receiving Additional Analgesics
Number of children receiving additional analgesics.
Measured: During the 60 min period post last dose of IMP

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 20249 May 2025

First posted15 Apr 2024
Study start27 May 2024
Primary completion9 May 2025
Study completion9 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 155 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06364072
Sponsor's protocol ID: PDC 01-0202
Other IDs: 2023-504023-63-00, 2023
Status last verified: Jan 2026
First submitted: 2 Apr 2024
Last updated: 2 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06364072
Acronym / sponsor ID: PDC 01-0202
Conditions: Pain
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 155 participants (actual)
Lead sponsor: Cessatech A/SIndustry (pharma, biotech, devices)
Study start: 27 May 2024 (actual)
Primary completion: 9 May 2025 (actual)
Study completion: 9 May 2025 (actual)
First posted: 15 Apr 2024 (actual)
Results: Posted 2 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CT001	Experimental	Drug: CT001

Who may qualify

Ages: 1 year to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (7 listed)

Participant showing abnormal nasal cavity/airway such as:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT001Intranasal	Drug	CT001

Primary outcome

Sedation
Time frame: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.
Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation.
Respiratory Depression
Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Respiratory depression assessed by respiratory rate.
Peripheral Oxygen Saturation
Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Peripheral oxygen saturation assessed by oxygen saturation rate (%)
Cardiovascular Stability
Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.
Cardiovascular stability assessed by pulse rate (bpm)
Number of Reported Adverse Events
Time frame: Through study completion; up to 7 days
Number of reported adverse events.
Number of Adverse Events (AEs) Reported Per Participant
Time frame: Through study completion; up to 7 days
Number of adverse events (AEs) reported per participant.
Local Nasal Irritation
Time frame: 30 and 60 min post IMP administration
The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation.
Analgesic Effect
Time frame: At baseline and at 15 and 30 min post first IMP dose
Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).

7 secondary outcomes

Treatment Satisfaction
Time frame: Prior to Emergency Department discharge (day of IMP administration)
Feasibility (Acceptance of Nasal Administration)
Time frame: Prior to Emergency Department discharge (day of IMP administration)
Medication Errors
Time frame: Assessed immediately post IMP administration
Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.
Time frame: 30 min post (first) IMP administration
Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline
Time frame: within 30 min post (first) IMP administration.
Change From Baseline in Pain Intensity
Time frame: at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration.
Number of Children Receiving Additional Analgesics
Time frame: During the 60 min period post last dose of IMP

Results and safety

Results posted to the registry on 2 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT001	155	154

Primary outcome: Sedation

Time frame: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.. Median (Inter-Quartile Range). Unit: UMSS score

Measure	CT001 n = 155
Baseline	0 (0 to 0)
10 min	0 (0 to 1)
15 min	1 (0 to 1)
20 min	1 (0 to 1)
30 min	1 (0 to 1)
45 min	0 (0 to 1)
60 min	0 (0 to 1)

Population analysed: Some participants had missing or non-assessable UMSS scores (e.g., early withdrawal, assessment not performed within the prespecified window, or incomplete data).

Primary outcome: Respiratory Depression

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.. Median (Standard Deviation). Unit: Respiratory rate (rpm)

Measure	CT001 n = 155
Age 1- <5 years, baseline	26 (6.09)
Age 1- <5 years, 10 min	24 (5.67)
Age 1- <5 years, 15 min	24 (5.27)
Age 1- <5 years, 20 min	23 (3.64)
Age 1- <5 years, 25 min	21 (3.44)
Age 1- <5 years, 30 min	22 (3.87)
Age 1- <5 years, 35 min	20 (4)
Age 1- <5 years, 45 min	22 (3.59)

Population analysed: The number analyzed differs across rows because pain intensity was assessed using age-appropriate scales, and not all participants had evaluable measurements at each time point. Some participants had missing or non-assessable pain scores (e.g., early withdrawal, assessment not performed within the prespecified window, or incomplete data), so they were excluded from the affected row(s), while remaining in the overall analyzed population.

Primary outcome: Peripheral Oxygen Saturation

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.. Median (Standard Deviation). Unit: Oxygen saturation rate (%)

Measure	CT001 n = 155
Age 1- <5 years, baseline	98 (1.05)
Age 1- <5 years, 10 min	98 (1.15)
Age 1- <5 years, 15 min	98 (1.17)
Age 1- <5 years, 20 min	98 (1.22)
Age 1- <5 years, 25 min	97 (1)
Age 1- <5 years, 30 min	98 (1.4)
Age 1- <5 years, 35 min	98 (0.89)
Age 1- <5 years, 45 min	99 (1.4)

Primary outcome: Cardiovascular Stability

Time frame: At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.. Median (Standard Deviation). Unit: Beats per minute

Measure	CT001 n = 155
Age 1- <5 years, baseline	117 (22.69)
Age 1- <5 years, 10 min	108 (17.78)
Age 1- <5 years, 15 min	111 (18.37)
Age 1- <5 years, 20 min	109 (16.7)
Age 1- <5 years, 25 min	118 (9.84)
Age 1- <5 years, 30 min	109 (16.5)
Age 1- <5 years, 35 min	117 (7.95)
Age 1- <5 years, 45 min	110 (12.91)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion; up to 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT001	4 of 155 (2.6%)	73 of 155 (47.1%)	0 of 155

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stuart Hartshorn, Dr. principal investigator

Birmingham Children's Hospital

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CT001 in people with Pain, run by Cessatech A/S at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sedation (time frame: At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06364072.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.