Trial · NCT06364072
Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
NCT06364072, Phase 2, Phase 3, Completed, Cessatech A/S; results first posted 2026-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients. Trials, record NCT06364072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06364072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients
- NCT number
- NCT06364072
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Cessatech A/S
- Conditions
- Pain
- Interventions
- CT001
- First posted
- 2024-04-15
- Last updated
- 2026-02-02
- Results first posted
- 2026-02-02
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sedation | 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. |
| Primary | Respiratory Depression | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | Respiratory depression assessed by respiratory rate. |
| Primary | Peripheral Oxygen Saturation | 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 (%) |
| Primary | Cardiovascular Stability | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | Cardiovascular stability assessed by pulse rate (bpm) |
| Primary | Number of Reported Adverse Events | Through study completion; up to 7 days | Number of reported adverse events. |
| Primary | Number of Adverse Events (AEs) Reported Per Participant | Through study completion; up to 7 days | Number of adverse events (AEs) reported per participant. |
| Primary | Local Nasal Irritation | 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. |
| Primary | Analgesic Effect | 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). |
| Secondary | Treatment Satisfaction | Prior to Emergency Department discharge (day of IMP administration) | 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)). |
| Secondary | Feasibility (Acceptance of Nasal Administration) | Prior to Emergency Department discharge (day of IMP 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". |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sedation | 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. | Some participants had missing or non-assessable UMSS scores (e.g., early withdrawal, assessment not performed within the prespecified window, or incomplete data). | UMSS score | MEDIAN |
| PRIMARY | Respiratory Depression | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | 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. | Respiratory rate (rpm) | MEDIAN |
| SECONDARY | Treatment Satisfaction | Prior to Emergency Department discharge (day of IMP administration) | Treatment satistaction score | MEDIAN | |
| PRIMARY | Peripheral Oxygen Saturation | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | 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. | Oxygen saturation rate (%) | MEDIAN |
| PRIMARY | Cardiovascular Stability | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. | 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. | Beats per minute | MEDIAN |
| PRIMARY | Number of Reported Adverse Events | Through study completion; up to 7 days | Adverse events | NUMBER | |
| PRIMARY | Number of Adverse Events (AEs) Reported Per Participant | Through study completion; up to 7 days | Adverse event per participant | NUMBER | |
| SECONDARY | Feasibility (Acceptance of Nasal Administration) | Prior to Emergency Department discharge (day of IMP administration) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Medication Errors | Assessed immediately post IMP administration | Participants | NUMBER | |
| SECONDARY | Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration. | 30 min post (first) IMP administration | Scores on a scale | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group131
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sedation | CT001 | Baseline | 0 | Inter-Quartile Range 0 to 0 | UMSS score |
| Sedation | CT001 | 10 min | 0 | Inter-Quartile Range 0 to 1 | UMSS score |
| Sedation | CT001 | 15 min | 1 | Inter-Quartile Range 0 to 1 | UMSS score |
| Sedation | CT001 | 20 min | 1 | Inter-Quartile Range 0 to 1 | UMSS score |
| Sedation | CT001 | 30 min | 1 | Inter-Quartile Range 0 to 1 | UMSS score |
| Sedation | CT001 | 45 min | 0 | Inter-Quartile Range 0 to 1 | UMSS score |
| Sedation | CT001 | 60 min | 0 | Inter-Quartile Range 0 to 1 | UMSS score |
| Respiratory Depression | CT001 | Age 1- <5 years, baseline | 26 | Standard Deviation 6.09 | Respiratory rate (rpm) |
| Respiratory Depression | CT001 | Age 1- <5 years, 10 min | 24 | Standard Deviation 5.67 | Respiratory rate (rpm) |
| Respiratory Depression | CT001 | Age 1- <5 years, 15 min | 24 | Standard Deviation 5.27 | Respiratory rate (rpm) |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CT001 | 155 | |
| Overall Study | COMPLETED | CT001 | 154 | |
| Overall Study | NOT COMPLETED | CT001 | 1 |
Source ClinicalTrials.gov
Adverse events27
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lacrimation increased | Eye disorders | CT001 | 1 | 155 | |
| other | Vision blurred | Eye disorders | CT001 | 1 | 155 | |
| other | Diarrhoea | Gastrointestinal disorders | CT001 | 1 | 155 | |
| other | Nausea | Gastrointestinal disorders | CT001 | 14 | 155 | |
| other | Vomiting | Gastrointestinal disorders | CT001 | 25 | 155 | |
| other | Product use complaint | Injury, poisoning and procedural complications | CT001 | 19 | 155 | |
| other | Decreased appetite | Metabolism and nutrition disorders | CT001 | 1 | 155 | |
| other | Dizziness | Nervous system disorders | CT001 | 22 | 155 | |
| other | Headache | Nervous system disorders | CT001 | 1 | 155 | |
| other | Hypoaesthesia | Nervous system disorders | CT001 | 1 | 155 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CT001 | 0 | 155 |
| Total, other adverse events | CT001 | 73 | 155 |
| Total, serious adverse events | CT001 | 4 | 155 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06364072
GET https://conductscience.org/api/trials/v1/NCT06364072/results?page=2