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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504023-63-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT001 | Drug | Intranasal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 (%) | 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) | 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. | Through study completion; up to 7 days |
| Number of Adverse Events (AEs) Reported Per Participant | Number of adverse events (AEs) reported per participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Hartshorn, Dr. | Birmingham Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Dr. Balmis | Alicante | Spain | ||||
| Hospital Sant Joan de Deu |
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Total number of participants enrolled in the study: 155 (83 in Spain and 72 in the United Kingdom).
There was no screen failures reported, only 1 participant was withdrawn from the study by the investigator due to pending surgical procedures which meant that the patient could not continue on the study.
There were 155 participants in the full analysis set and in the safety population and 152 participants included in the efficacy analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | CT001 | All participants received one or potentially two consecutive doses of CT001. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT001 | All participants received one or potentially two consecutive doses of CT001. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some participants had missing or non-assessable UMSS scores (e.g., early withdrawal, assessment not performed within the prespecified window, or incomplete data). | Posted | Median | Inter-Quartile Range | UMSS score | 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. |
|
Through study completion; up to 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT001 | All participants received one or potentially two consecutive doses of CT001. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Juhl | Cessatech A/S | 30833325 | martin.juhl@cessatech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2024 | Oct 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. | 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). | At baseline and at 15 and 30 min post first IMP dose |
| 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". | 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. | 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). | 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). | 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). | 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. | During the 60 min period post last dose of IMP |
| Barcelona |
| Spain |
| Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) - | Madrid | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela | Spain |
| Birmingham Women's and Children's NHS Foundation Trust | Birmingham | United Kingdom |
| Royal London Hospital | London | United Kingdom |
| Sheffield Children's Hospital | Sheffield | United Kingdom |
| Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Baseline pain intensity score | 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). | Median | Inter-Quartile Range | Score on a scale (0-10) |
|
All participants received one or potentially two consecutive doses of CT001. |
|
|
| Primary | Respiratory Depression | Respiratory depression assessed by respiratory rate. | 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. | Posted | Median | Standard Deviation | Respiratory rate (rpm) | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. |
|
|
|
| Secondary | 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)). | Posted | Median | Inter-Quartile Range | Treatment satistaction score | Prior to Emergency Department discharge (day of IMP administration) |
|
|
|
| Primary | Peripheral Oxygen Saturation | Peripheral oxygen saturation assessed by oxygen saturation rate (%) | 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. | Posted | Median | Standard Deviation | Oxygen saturation rate (%) | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. |
|
|
|
| Primary | Cardiovascular Stability | Cardiovascular stability assessed by pulse rate (bpm) | 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. | Posted | Median | Standard Deviation | Beats per minute | At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration. |
|
|
|
| Primary | Number of Reported Adverse Events | Number of reported adverse events. | Posted | Number | Adverse events | Through study completion; up to 7 days |
|
|
|
| Primary | Number of Adverse Events (AEs) Reported Per Participant | Number of adverse events (AEs) reported per participant. | Posted | Number | Adverse event per participant | Through study completion; up to 7 days |
|
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | Prior to Emergency Department discharge (day of IMP administration) |
|
|
|
| Secondary | 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. | Posted | Number | Participants | Assessed immediately post IMP administration |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | Scores on a scale | 30 min post (first) IMP administration |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | within 30 min post (first) IMP administration. |
|
|
|
| Secondary | 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). | Only patients who had evaluable pain-intensity measurements for the relevant endpoint/time point are included in this outcome measure. Although 155 patients were treated and included in the overall safety population, some did not have a valid post-baseline assessment (e.g., missing measurement, assessment outside the prespecified window, early discontinuation, or other clinical/technical reasons). | Posted | Median | Inter-Quartile Range | Scores on a scale | at 10, 15, 20, 30, 45 and 60 min post last dose of IMP administration. |
|
|
|
| Primary | 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. | Posted | Number | Number of participants | 30 and 60 min post IMP administration |
|
|
|
| Primary | 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). | As the results include two time points, some participants are represented in more than one category. | Posted | Count of Participants | Participants | At baseline and at 15 and 30 min post first IMP dose |
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|
| Secondary | Number of Children Receiving Additional Analgesics | Number of children receiving additional analgesics. | Posted | Number | participants | During the 60 min period post last dose of IMP |
|
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|
| 0 |
| 155 |
| 4 |
| 155 |
| 73 |
| 155 |
| Vision blurred | Eye disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Product use complaint | Injury, poisoning and procedural complications | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | Systematic Assessment |
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| Abnormal behaviour | Psychiatric disorders | Systematic Assessment |
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| Anger | Psychiatric disorders | Systematic Assessment |
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| Confusional state | Psychiatric disorders | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | Systematic Assessment |
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| Mood altered | Psychiatric disorders | Systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal pruritus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hospitalisation | Surgical and medical procedures | Systematic Assessment |
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| Hot flush | Vascular disorders | Systematic Assessment |
|
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| Age 1- <5 years, 15 min |
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| Age 1- <5 years, 20 min |
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| Age 1- <5 years, 25 min |
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| Age 1- <5 years, 30 min |
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| Age 1- <5 years, 35 min |
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| Age 1- <5 years, 45 min |
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| Age 1- <5 years, 60 min |
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| Age 1- <5 years, 75 min |
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| Age 5- <9 years, baseline |
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| Age 5- <9 years, 10 min |
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| Age 5- <9 years, 15 min |
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| Age 5- <9 years, 20 min |
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| Age 5- <9 years, 25 min |
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| Age 5- <9 years, 30 min |
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| Age 5- <9 years, 35 min |
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| Age 5- <9 years, 45 min |
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| Age 5- <9 years, 60 min |
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| Age 5- <9 years, 75 min |
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| Age 9- <18 years, baseline |
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| Age 9- <18 years, 10 min |
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| Age 9- <18 years, 15 min |
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| Age 9- <18 years, 20 min |
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| Age 9- <18 years, 25 min |
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| Age 9- <18 years, 30 min |
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| Age 9- <18 years, 35 min |
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| Age 9- <18 years, 45 min |
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| Age 9- <18 years, 60 min |
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| Age 9- <18 years, 75 min |
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| Age 1- <5 years, 15 min |
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| Age 1- <5 years, 20 min |
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| Age 1- <5 years, 25 min |
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| Age 1- <5 years, 30 min |
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| Age 1- <5 years, 35 min |
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| Age 1- <5 years, 45 min |
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| Age 1- <5 years, 60 min |
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| Age 1- <5 years, 75 min |
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| Age 5- <9 years, baseline |
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| Age 5- <9 years, 10 min |
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| Age 5- <9 years, 15 min |
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| Age 5- <9 years, 20 min |
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| Age 5- <9 years, 25 min |
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| Age 5- <9 years, 30 min |
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| Age 5- <9 years, 35 min |
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| Age 5- <9 years, 45 min |
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| Age 5- <9 years, 60 min |
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| Age 5- <9 years, 75 min |
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| Age 9- <18 years, baseline |
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| Age 9- <18 years, 10 min |
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| Age 9- <18 years, 15 min |
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| Age 9- <18 years, 20 min |
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| Age 9- <18 years, 25 min |
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| Age 9- <18 years, 30 min |
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| Age 9- <18 years, 35 min |
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| Age 9- <18 years, 45 min |
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| Age 9- <18 years, 60 min |
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| Age 9- <18 years, 75 min |
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| Age 1- <5 years, 15 min |
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| Age 1- <5 years, 20 min |
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| Age 1- <5 years, 25 min |
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| Age 1- <5 years, 30 min |
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| Age 1- <5 years, 35 min |
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| Age 1- <5 years, 45 min |
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| Age 1- <5 years, 60 min |
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| Age 1- <5 years, 75 min |
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| Age 5- <9 years, baseline |
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| Age 5- <9 years, 10 min |
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| Age 5- <9 years, 15 min |
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| Age 5- <9 years, 20 min |
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| Age 5- <9 years, 25 min |
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| Age 5- <9 years, 30 min |
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| Age 5- <9 years, 35 min |
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| Age 5- <9 years, 45 min |
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| Age 5- <9 years, 60 min |
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| Age 5- <9 years, 75 min |
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| Age 9- <18 years, baseline |
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| Age 9- <18 years, 10 min |
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| Age 9- <18 years, 15 min |
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| Age 9- <18 years, 20 min |
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| Age 9- <18 years, 25 min |
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| Age 9- <18 years, 30 min |
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| Age 9- <18 years, 35 min |
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| Age 9- <18 years, 45 min |
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| Age 9- <18 years, 60 min |
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| Age 9- <18 years, 75 min |
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| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| 25 min (2 doses) |
|
| 30 min |
|
| 35 min (2 doses) |
|
| 45 min |
|
| 60 min |
|
| 75 min (2 doses) |
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| Nasal discharge, 60 min post IMP |
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| Other nasal irritation, 30 min post IMP |
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| Other nasal irritation, 60 min post IMP |
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| Redness, 30 min post IMP |
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| Redness, 60 min post IMP |
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| Sneezing, 30 min post IMP |
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| Sneezing, 60 min post IMP |
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| Participants with pain intensity > 4 at 30min post first dose of CT001 |
|