Clinical Trial Results:
Effect of high versus low dose intravenous dexamethason on complications in the immediate postoperative setting after periacetabular osteotomy- a randomized, double-blind, controlled trial.
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Summary
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EudraCT number |
2017-000544-17 |
Trial protocol |
DK |
Global end of trial date |
20 Sep 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Apr 2020
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First version publication date |
19 Apr 2020
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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 |
DEXGANZ01
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03161938 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Eske K Aasvang
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Kristin Julia Steinthorsdottir, Rigshospitalet, 0045 31666112, kjs@dadlnet.dk
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Scientific contact |
Kristin Julia Steinthorsdottir, Rigshospitalet, 31666112 31666112, kjs@dadlnet.dk
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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? |
No
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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 |
03 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Sep 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Sep 2019
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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 |
To investigate the effects of high versus low dose glucorticoids on pain after periacetabular osteotomy
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Protection of trial subjects |
All trial subjects underwent standard procedures, only difference was the dosage of dexamethasone
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 64
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Worldwide total number of subjects |
64
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EEA total number of subjects |
64
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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) |
0
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Adults (18-64 years) |
64
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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 |
Denmark, 1/5-2017 to 20/8-2019 | |||||||||
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Pre-assignment
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Screening details |
Eligible patients are informed about the trial in relation to the pre-operative appointment. Enrolled participants are randomized and assigned to consecutive numbers (1-64) at the morning of surgery. Inclusion criteria • Planned PAO • Age 18 years or older • Able to understand Danish or English and to provide informed oral and written consent | |||||||||
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Period 1
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Period 1 title |
overall (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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48 mg dexamethasone | |||||||||
Arm description |
48 mg dexamethasone | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
single-dose intravenous
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Arm title
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8 mg dexamethasone | |||||||||
Arm description |
8 mg dexamethasone | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
single-dose intravenous
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Baseline characteristics reporting groups
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Reporting group title |
overall
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
48 mg dexamethasone
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Reporting group description |
48 mg dexamethasone | ||
Reporting group title |
8 mg dexamethasone
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Reporting group description |
8 mg dexamethasone | ||
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End point title |
Pain in the PACU | |||||||||
End point description |
The primary endpoint was the proportion of patients reporting moderate to severe pain at rest (>3 out of 10 on a Numeric Rating Scale from 0-10 (NRS)) in the immediate postoperative phase (after extubation in the operating room, and in the PACU until transfer to the ward).
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End point type |
Primary
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End point timeframe |
12 hours
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Statistical analysis title |
primary outcome fischers | |||||||||
Comparison groups |
48 mg dexamethasone v 8 mg dexamethasone
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Number of subjects included in analysis |
64
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
= 0.248 | |||||||||
Method |
Chi-squared corrected | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
0.508
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.159 | |||||||||
upper limit |
1.62 | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
60 hours after administration of trial drug
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | |||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
48 mg dexamethasone
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Reporting group description |
48 mg dexamethasone | |||||||||||||||||||||||||||||||||
Reporting group title |
8 mg dexamethasone
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Reporting group description |
8 mg dexamethasone | |||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
