Clinical Trial Results:
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for
sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for
marketing registration of Dexdor
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Summary
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EudraCT number |
2018-003063-64 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
21 May 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Dec 2018
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First version publication date |
06 Dec 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
3005031
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Orion Corporation, Orion Pharma
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Sponsor organisation address |
Orionintie 1, Espoo, Finland, 02200
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Public contact |
Clinical Trial Information Desk, Orion Corporation, Orion Pharma, 358 104261, clinicaltrials@orionpharma.com
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Scientific contact |
Clinical Trial Information Desk, Orion Corporation, Orion Pharma, 358 104261, clinicaltrials@orionpharma.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
21 May 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Evaluation of efficacy of Dexdor for prolonged sedation in paediatric patients;
Evaluation of safety and tolerability of Dexdor in paediatric population.
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Protection of trial subjects |
Sedation level was monitored throughout the study, and rescue and pain medication was administered, when needed. Vital signs (e.g. heart rate, systolic and diastolic blood pressure, body temperature, ventilation frequency (for patients with spontaneous ventilation)) was assessed frequently after start of study treatment.
Continuous cardiac and respiratory monitoring was done throughout the study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Russian Federation: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
60
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Children aged 12-17 years, with clinical need for prolonged sedation were recruited in 5 study centers in Russian. | ||||||||||
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Pre-assignment
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Screening details |
The investigator assessed and pre-screened patients staying in ICU. Clinical situations that need prolonged sedation were e.g. trauma, injuries or surgical corrections. Patients with clinical need for prolonged (at least 24h) sedation (target RASS = 0 to -3), and who met all the inclusion criteria and none of the exclusion criteria were included. | ||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Dexdor infusion | ||||||||||
Arm description |
Dexdor was administered as follows: the starting dose is 0.7 mcg/kg/h for 1 hour, then down- or up-titrating with 0.1–0.4 mcg/kg/h steps every 30 minutes depending on sedation level; additional analgesics as needed. In case of inadequate sedation at the highest dose (1.4 mcg/kg/h) another sedative medication (according to accepted standards in each hospital) were carefully added to sedation. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Dexmedetomidine 100 microg/ml
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Starting dose 0.7 microg/kg/h for 1 hour, then down- or up-titrating with 0.1–0.4 microg/kg/h steps every 30 minutes depending on sedation level.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dexdor infusion
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Reporting group description |
Dexdor was administered as follows: the starting dose is 0.7 mcg/kg/h for 1 hour, then down- or up-titrating with 0.1–0.4 mcg/kg/h steps every 30 minutes depending on sedation level; additional analgesics as needed. In case of inadequate sedation at the highest dose (1.4 mcg/kg/h) another sedative medication (according to accepted standards in each hospital) were carefully added to sedation. | ||
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End point title |
Percentage of patients requiring additional analgesics and sedatives [1] | ||||||
End point description |
Percentage of patients requiring additional analgesics and sedatives (with calculation of cumulative dose per hour for each particular medication).
RESULT: 0.9825 % of patients didn't need additional sedatives or analgesics (90% C.I. 0.8776-0.9977).
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End point type |
Primary
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End point timeframe |
From start of the treatment up to maximum 5 days
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical results are reported in End point description-field, due to technical reasons (only one treatment group, no comparisons). |
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| No statistical analyses for this end point | |||||||
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End point title |
The time spent in target sedation range [2] | ||||||
End point description |
Maintaining the target sedation level endpoint was defined as the proportion of time during study treatment with a RASS score within the individually-prescribed target range without rescue medication. The total amount of time that the patient remains within their target RASS range without rescue medication were divided by the amount of time of the treatment period.
RESULT: Proportion of time within the target sedation range without rescue medication. Mean % (SD) 88.9 (9.9), N=57,
Proportion of time within the target sedation range without rescue medication: Estimate of the least squares mean, 90% C.I.: 92.2 ( 86.04, 95.80). N=57
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End point type |
Primary
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End point timeframe |
From start of the treatment up to maximum 5 days
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical results are reported in End point description-field, due to technical reasons (only one treatment group, no comparisons). |
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
From signing an informed consent up to end of study visit on the 7th day after stopping the study treatment
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Adverse event reporting additional description |
Safety population = patients who received at least one dose of study treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Dexdor infusion
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Reporting group description |
Safety population = subjects who received at least one dose of study treatment. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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22 Jun 2017 |
Down- and up-titrating steps of Dexdor infusion were changed to allow more individual dosing. Assessment of efficacy variables was clarified (baseline RASS assessment was added). List of indications for planned administration of the investigational product was updated. |
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02 Sep 2017 |
List of indications for planned administration of the investigational product was updated. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
