AnalgesiaPhase 2NCT04897750
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
A Phase 2 study testing CT001 in people with Analgesia, run by Cessatech A/S at 1 site in Denmark.
Trial summary
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Analgesia
- What is being tested?
- CT001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Aug 2021to 16 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Paediatric participants, age 1-17 years at the day of the surgical procedure
- Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
- ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
- Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
- Needs premedication before induction of anaesthesia as determined by investigator
- Informed consent by the legally acceptable representative(s)
- The legally acceptable representative(s) and patients 15-17 years must be able to understand and speak local language
- A female participant who has onset of menarche is eligible to participate if she is not pregnant, not breastfeeding and agree to follow the contraceptive guidance during the treatment period for at least 7 days after administration of study treatment.
Who cannot join
- Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
- Mental retardation
- Abnormal nasal cavity or nasal obstruction
- Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
- Medical history including substance or alcohol abuse
- Has received treatment with sufentanil and/or ketamine during the last 72 hours prior to surgery
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- Has planned perioperative administration of sufentanil and/or ketamine
- Has or is suspected of having a family or personal history of malignant hyperthermia
- Has or is suspected of having allergies to ketamine or sufentanil
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Anæstesi- og Operationsafdelingen 4013 Juliane Marie Centeret
Copenhagen, Region H, 2100
About this study
Official title: Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years.
- Conditions
- Analgesia
- Being tested
- CT001
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT001Combination product
Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia. Receives: Combination Product: CT001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total absorption over time
Area under the concentration vs time curve
Measured: 0 - 120 minutes
Maximum absorption
Peak concentration (Cmax)
Measured: 0 - 120 minutes
Distribution
Volumen of distribution (Vd)
Measured: 120 - 240 minutes
Elimination
Half life (T½)
Measured: 120 - 240 minutes
Elimination
Clearance,
Measured: 120 - 240 minutes
Secondary outcomes (3)
Analgetic effect
pain intensity by age-appropriate scale in relation to the placement of peripheral venous catheter
Measured: 0 - 1 hour
Sedation
Assessment of sedation at the time of placement of the peripheral venous catheter using the University of Michigan Sedation Score
Measured: 0 - 1 hour
Feasibility, (Acceptance of intranasal administration)
Acceptance of the intranasal route of administration by the child, assessed by the child or legally acceptable representative or health care provider.
Measured: 0- 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start19 Aug 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cessatech A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volker Classen, MD, Principal investigator, Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897750
- Sponsor's protocol ID
- PDC 01-0206
- Status last verified
- Apr 2022
- First submitted
- 14 May 2021
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures.
- ClinicalTrials.gov ID
- NCT04897750
- Acronym / sponsor ID
- PDC 01-0206
- Conditions
- Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cessatech A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective non-randomized, open-label, single dose (and a second dose if needed), PK study in 25 children age 1-17 years. The proposed number of study participants by subset is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9 paediatric participants >6-17 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Combination Product: CT001a target dose of intranasal sufentanil 0,5 mcg/kg + ketamine 0,5 mg/kg, (2-4 puffs) and an additional dose if needed as premedication before placement of a PVC for induction of anaesthesia. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Paediatric participants, age 1-17 years at the day of the surgical procedure
- Planned for elective surgical procedures (e.g. hernia, orchiopexy, gastroscopy, cystoscopy)
- ASA (American Society of Anaesthesiologists) physical status classification system score 1-2 as determined by investigator
- Planned for induction of anaesthesia by an intravenous anaesthetic agent, requiring placement of peripheral venous catheter immediately prior to the surgical procedure
- Needs premedication before induction of anaesthesia as determined by investigator
Key exclusion criteria (9 listed)
- Ex-premature infant (born <37 weeks AND less than 60 weeks post conceptual age at the day of the surgical procedure)
- Mental retardation
- Abnormal nasal cavity or nasal obstruction
- Clinical contraindications to narcotic analgesia including head injury or any condition that can in the opinion of the investigator, deteriorate safety and well-being of the participants, influence PK data or optimal participation in the trial
- Medical history including substance or alcohol abuse
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 |
|---|---|---|
| CT001Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed. | Combination product | Active |
Primary outcome
Total absorption over time
Time frame: 0 - 120 minutes
Area under the concentration vs time curve
Maximum absorption
Time frame: 0 - 120 minutes
Peak concentration (Cmax)
Distribution
Time frame: 120 - 240 minutes
Volumen of distribution (Vd)
Elimination
Time frame: 120 - 240 minutes
Half life (T½)
Elimination
Time frame: 120 - 240 minutes
Clearance,
3 secondary outcomes
Analgetic effect
Time frame: 0 - 1 hour
Sedation
Time frame: 0 - 1 hour
Feasibility, (Acceptance of intranasal administration)
Time frame: 0- 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Volker Classen, MD principal investigator
Department of Anaesthesiology, The Juliane Marie Centre Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT001 in people with Analgesia, run by Cessatech A/S at 1 site in Denmark.
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 8 inclusion and 9 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total absorption over time (time frame: 0 - 120 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2022.