Clinical Trial Results:
Preoperative methylprednisolone to patients suspected of appendicitis undergoing laparoscopy.
Summary
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EudraCT number |
2015-004800-46 |
Trial protocol |
DK |
Global end of trial date |
23 Sep 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Nov 2017
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First version publication date |
22 Nov 2017
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Other versions |
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 |
2015-810
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Kirurgisk Afdeling, Nordsjællands Hospital
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Sponsor organisation address |
Dyrehavevej 29, Hillerød, Denmark,
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Public contact |
Jakob Kleif, Kirurgisk Afdeling, Nordsjællands Hospital, jakob.kleif@regionh.dk
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Scientific contact |
Jakob Kleif, Kirurgisk Afdeling, Nordsjællands Hospital, jakob.kleif@regionh.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 |
23 Sep 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Sep 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2016
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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 test whether preoperative methylprednisolone can reduce postoperative pain after laparoscopy for suspected appendicitis.
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Protection of trial subjects |
None
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2016
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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: 78
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Worldwide total number of subjects |
78
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EEA total number of subjects |
78
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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) |
72
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From 65 to 84 years |
5
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85 years and over |
1
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Recruitment
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Recruitment details |
From 12.04.2016 to 24.08.2016 127 were eligible, 78 patients were included and randomised. | |||||||||
Pre-assignment
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Screening details |
Screen by attending surgeon. | |||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Saline
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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/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
2 ml Saline
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Arm title
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Methylprednisolone | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Methylprednisolone
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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/infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
125 mg (2 ml) Methylprednisolone.
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Methylprednisolone
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Reporting group description |
- |
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End point title |
Pain during the first 3 postoperative days | ||||||||||||
End point description |
The analysis was made using repeated measures. Therefore the mean for each study group is not reported. (Written as zero because the system needs a value).
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End point type |
Primary
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End point timeframe |
3 first postoperative days
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Statistical analysis title |
Difference in Pain the first 3 postoperative days | ||||||||||||
Comparison groups |
Placebo v Methylprednisolone
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Number of subjects included in analysis |
78
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.571 | ||||||||||||
Method |
Mixed models analysis | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.2
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.5 | ||||||||||||
upper limit |
0.9 |
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Adverse events information
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Timeframe for reporting adverse events |
30 days postoperative.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Clavien-dindo | ||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
Placebo (saline)
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Reporting group description |
- | ||||||||||||||||||||||||||||||
Reporting group title |
Methylprednisolon
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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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? 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 |