Trial · NCT03366298
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
NCT03366298, Phase 4, Completed, Imperial College London; results first posted 2021-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers. Trials, record NCT03366298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03366298
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers
- NCT number
- NCT03366298
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Imperial College London
- Conditions
- Anaphylaxis
- Interventions
- Epipen 0.3mg, Emerade 300mcg, Emerade 500mcg
- First posted
- 2017-12-08
- Last updated
- 2022-09-07
- Other registries' IDs
- eudract:2017-003239-13
- Results first posted
- 2021-04-05
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Catecholamine Levels (Maximum Concentration, Cmax) | 3 hours | Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| Primary | Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | 3 hours | Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| Primary | Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes | Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. Baseline corrected. |
| Secondary | Change in Heart Rate Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | Pharmacodynamics (heart rate) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| Secondary | Change in Blood Pressure Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | Pharmacodynamics (blood pressure) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| Secondary | Change in Stroke Volume Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | Pharmacodynamics (stroke volume) following intramuscular self-injection of 300mcg and 500mcg adrenaline using an auto-injector device, in food-allergic teenagers over 40kg. |
| Secondary | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Cmax) | 3 hours | Pharmacokinetics (plasma catecholamine levels: Cmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg. |
| Secondary | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Tmax) | 3 hours | Pharmacokinetics (plasma catecholamine levels: Tmax) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg. |
| Secondary | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: AUC) | 3 hours | Pharmacokinetics (plasma catecholamine levels: AUC) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg. |
| Secondary | Impact of Needle Length on Pharmacodynamics (Cardiovascular Parameters: Heart Rate) | 3 hours | The pharmacodynamics (cardiovascular parameters: heart rate) following intramuscular self-injection of 300mcg adrenaline using two auto-injector devices with different needle lengths (15mm vs 23mm), in food-allergic teenagers over 40kg. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Catecholamine Levels (Maximum Concentration, Cmax) | 3 hours | pg/ml | MEAN | |
| PRIMARY | Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | 3 hours | minutes | MEAN | |
| PRIMARY | Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | At at the following timepoints following injection: 5, 10, 15, 20, 30, 45, 60, 80, 100, 120 and 180 minutes | hr*pg/ml | MEAN | |
| SECONDARY | Change in Heart Rate Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | |||
| SECONDARY | Change in Blood Pressure Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | |||
| SECONDARY | Change in Stroke Volume Following Self-injection of Adrenaline (300mcg, 500mcg) on Separate Occasions. | 3 hours | |||
| SECONDARY | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Cmax) | 3 hours | |||
| SECONDARY | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: Tmax) | 3 hours | |||
| SECONDARY | Impact of Needle Length on Pharmacokinetics (Plasma Catecholamine Levels: AUC) | 3 hours | |||
| SECONDARY | Impact of Needle Length on Pharmacodynamics (Cardiovascular Parameters: Heart Rate) | 3 hours |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Catecholamine Levels (Maximum Concentration, Cmax) | Emerade 300mcg Injection | 218 | 95% Confidence Interval 132 to 359 | pg/ml | |
| Plasma Catecholamine Levels (Maximum Concentration, Cmax) | Emerade 500mcg Injection | 394 | 95% Confidence Interval 310 to 500 | pg/ml | |
| Plasma Catecholamine Levels (Maximum Concentration, Cmax) | Epipen 0.3mg | 290 | 95% Confidence Interval 200 to 421 | pg/ml | |
| Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | Emerade 300mcg Injection | 9.6 | 95% Confidence Interval 5.3 to 17.4 | minutes | |
| Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | Emerade 500mcg Injection | 8.5 | 95% Confidence Interval 6.1 to 11.8 | minutes | |
| Plasma Catecholamine Levels (Time to Maximum Concentration, Tmax) | Epipen 0.3mg | 5.9 | 95% Confidence Interval 4.9 to 7.3 | minutes | |
| Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | Emerade 300mcg Injection | 174 | 95% Confidence Interval 86 to 354 | hr*pg/ml | |
| Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | Emerade 500mcg Injection | 387 | 95% Confidence Interval 263 to 570 | hr*pg/ml | |
| Plasma Catecholamine Levels (Maximum Concentration, Area-under-curve (AUC)) | Epipen 0.3mg | 203 | 95% Confidence Interval 142 to 292 | hr*pg/ml | |
| Adverse Events Following Self-administration of Adrenaline Via Autoinjector Device | Emerade 300mcg Injection | Pain at injection site | 8 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Emerade 300 / Epipen 0.3mg / Emerade 500 | 3 | |
| Overall Study | STARTED | Epipen 0.3mg / Emerade 300 / Emerade 500 | 3 | |
| Overall Study | STARTED | Emerade 500 / Emerade 300 / Epipen 0.3mg | 3 | |
| Overall Study | STARTED | Emerade 500 / Epipen 0.3mg / Emerade 300 | 3 | |
| Overall Study | COMPLETED | Emerade 300 / Epipen 0.3mg / Emerade 500 | 3 | |
| Overall Study | COMPLETED | Epipen 0.3mg / Emerade 300 / Emerade 500 | 3 | |
| Overall Study | COMPLETED | Emerade 500 / Emerade 300 / Epipen 0.3mg | 3 | |
| Overall Study | COMPLETED | Emerade 500 / Epipen 0.3mg / Emerade 300 | 3 | |
| Overall Study | NOT COMPLETED | Emerade 300 / Epipen 0.3mg / Emerade 500 | 0 | |
| Overall Study | NOT COMPLETED | Epipen 0.3mg / Emerade 300 / Emerade 500 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
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 | Palpitations | Cardiac disorders | Emerade 300mcg Injection | 3 | 12 | 3 |
| other | Palpitations | Cardiac disorders | Emerade 500mcg Injection | 4 | 12 | 4 |
| other | Palpitations | Cardiac disorders | Epipen 0.3mg | 3 | 12 | 3 |
| other | Tremor | Nervous system disorders | Emerade 300mcg Injection | 3 | 12 | 3 |
| other | Tremor | Nervous system disorders | Emerade 500mcg Injection | 7 | 12 | 7 |
| other | Tremor | Nervous system disorders | Epipen 0.3mg | 8 | 12 | 8 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Emerade 300mcg Injection | 0 | 12 |
| Total, all-cause mortality | Emerade 500mcg Injection | 0 | 12 |
| Total, all-cause mortality | Epipen 0.3mg | 0 | 12 |
| Total, other adverse events | Emerade 300mcg Injection | 4 | 12 |
| Total, other adverse events | Emerade 500mcg Injection | 9 | 12 |
| Total, other adverse events | Epipen 0.3mg | 8 | 12 |
| Total, serious adverse events | Emerade 300mcg Injection | 0 | 12 |
| Total, serious adverse events | Emerade 500mcg Injection | 0 | 12 |
| Total, serious adverse events | Epipen 0.3mg | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36794963 | DERIVED |
Source PubMed
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/NCT03366298
GET https://conductscience.org/api/trials/v1/NCT03366298/results?page=2