Clinical Trial Results:
Glucocorticoid-induced inhibition of IGF-I activity: exploration of underlying mechanisms.
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Summary
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EudraCT number |
2012-003504-12 |
Trial protocol |
DK |
Global end of trial date |
20 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jan 2022
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First version publication date |
11 Jan 2022
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Other versions |
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Summary report(s) |
Results |
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 |
GK_nilani_2012
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01762540 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Aarhus University Hospital
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Sponsor organisation address |
Nørrebrogade 44, Aarhus, Denmark, 8000
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Public contact |
Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital, 0045 78461615,
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Scientific contact |
Medical Research Laboratory, Clinical Institute of Medicine, Aarhus University Hospital, 0045 78461615,
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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 |
01 Jul 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
20 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Jun 2014
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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 |
The main purpose of the tríal is to advance our knowledge on the possible mechanism underlying the catabolic effects of long-term treatment with glucocorticoid. It aimed to elucidate the catabolic impact of five days of high-dose prednisolone treatment on the GH/IGF-system in healthy young men.
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Protection of trial subjects |
All participants gave written, informed consent in accordance with the Declaration of Helsinki II. The study was conducted after approval from The Regional Scientific Ethical Committee and Danish Health and Medicine Authority. The study was monitored by the local GCP (Good Clinical Practice) unit to ensure international ethical and scientific quality standards.
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Background therapy |
The study was designed as a randomized, double-blinded, placebo-controlled crossover trial with 5 days of oral prednisolon treatment (37.5 mg once daily in the morning) and 5 days of placebo treatment (one daily in the morning). Each study session was separated by a wash-out period of minimum 4 weeks. The prednisolone dose (37,5mg/d) results in supraphysiological glucocorticoid effects, but the dose is clinically relevant and normally well tolerated during short-term treatment. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Dec 2012
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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: 19
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Worldwide total number of subjects |
19
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EEA total number of subjects |
19
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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) |
19
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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 |
Subjects were recruited via www.forsøgsperson.dk - a danish webpage for researchers to present clinical trials og recruit study participants. Only projects approved by the Danish Scientific Ethical Comittee can be published on the webpage. | |||||||||
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Pre-assignment
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Screening details |
Screeningsproces: routine biochemical testing, a medical interview, and a physical examination. Inclusion criteria: healthy men, age 20-30, BMI 19-26, written consent. Exclusion criteria: medical og mental diagnosis, allergi for trial drug, daily medicin intake, actual or prior (<1y) participation in trials using Washout period: minimum 4 weeks | |||||||||
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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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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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 |
randomization | |||||||||
Investigational medicinal product name |
Calcium Supplement
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard + tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1 tablet daily for 5 days
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Arm title
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Prednisolone | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Prednisolone DAK
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard + tablet
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Routes of administration |
Oral use
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Dosage and administration details |
1 tablet of 37.5mg daily for 5 days
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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 |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Prednisolone
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Reporting group description |
- | ||
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End point title |
Tissue specific IGF bioactivity | |||||||||
End point description |
Comparison of compartments after 5 days of treatment with prednisolone vs. placebo: The ratio between analyte concentrations in SBF vs serum
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End point type |
Primary
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End point timeframe |
Day 5 of placebo and prednisolone treatment.
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Statistical analysis title |
Paired difference estimates | |||||||||
Comparison groups |
Placebo v Prednisolone
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Number of subjects included in analysis |
19
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
All subjects were followed for 1 week after each session to record any adverse events. In the event of any adverse events during trial, participants were closely followed until remission of symptoms.
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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 |
1
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Reporting groups
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Reporting group title |
Trial participants
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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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 | |||
