E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
We investigate the reversal of opioid overdoses in the pre hospital setting |
|
E.1.1.1 | Medical condition in easily understood language |
Opioid overdoses outside of hospital |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022117 |
E.1.2 | Term | Injury, poisoning and procedural complications |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10071947 |
E.1.2 | Term | Exposures, chemical injuries and poisoning |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10035777 |
E.1.2 | Term | Poisoning and toxicity |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10070863 |
E.1.2 | Term | Toxicity to various agents |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10072946 |
E.1.2 | Term | Opioid toxicity |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Measure and evaluate clinical response to nasal naloxone in real opioid overdoses in the pre hospital environment.
|
|
E.2.2 | Secondary objectives of the trial |
Suitability of spray device in the pre hospital setting and adverse reactions |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
− Suspected opioid overdose clinically diagnosed by Emergency Medical Staff (EMS) based on the following criteria
1. Reduced (below or equal to 8 breaths per minute) or absent spontaneous respiration
2. Miosis
3. Glasgow Coma Scale (GCS) below 12
and
− Palpable carotid or radial arterial pulse
|
|
E.4 | Principal exclusion criteria |
− Cardiac arrest
− Failure to assist ventilation using mask- bag technique
− Facial trauma or epistaxis or visible nasal blockage
− Iatrogenic opioid overdose when opioid is administered in- hospital, or by EMS in the pre hospital setting
− Suspected participant below 18 years of age
− Participant visibly pregnant
− Participant that have received nasal naloxone by non- EMS staff in the current overdose
− EMS staff without adequate training as study workers
− No study drug available
− Deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for EMS.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with return of spontaneous respiration (above or equal to 10 breaths per minute) within 10 minutes of naloxone administration in pre hospital opioid overdose. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
10 minute with approximately additional 30 minutes observation time |
|
E.5.2 | Secondary end point(s) |
• Changes in Glasgow Coma Scale and oxygen saturation in patients treated with study medicine for opioid overdose.
• Overdose complications (e.g. aspiration, cardiac arrest, death)
• Time from administration of naloxone to respiration above or equal to 10 breaths per minute.
• Opioid withdrawal reaction to naloxone reversal
• Suitability of spray device in pre hospital setting
• Adverse reactions to naloxone formulation
• Need for rescue naloxone, dose and route of administration during study visit
• Recurrence of opioid overdose/ need for further pre hospital naloxone within 12 hours of inclusion
• Collect data regarding reasons not to give rescue naloxone to non-responders
• Baseline ambulance data such as dispatch times and baseline demographic variables of included and excluded participants.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
as for primary endpoint + additional check 12 hours later for overdose recurrence |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
double dummy, double blinded RCT |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of trial is last included patient + 14 days |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | |