Clinical Trial Results:
FTO-genotype dependent weight reduction under treatment with bromocriptin in obese patients
Summary
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EudraCT number |
2011-005628-16 |
Trial protocol |
DE |
Global end of trial date |
03 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2021
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First version publication date |
13 Dec 2021
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Other versions |
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Summary report(s) |
Synopsis |
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 |
Uni-Koeln-1473
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Additional study identifiers
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ISRCTN number |
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US NCT number |
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WHO universal trial number (UTN) |
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Other trial identifiers |
DRKS-Number: DRKS00003349 | ||
Sponsors
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Sponsor organisation name |
University of Cologne
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Sponsor organisation address |
Kerpener Str. 62, Köln, Germany, 50924
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Public contact |
Dr. Michael Faust, University of Cologne, 0049 02214784098, michael.faust@uk-koeln.de
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Scientific contact |
Dr. Michael Faust, University of Cologne, 0049 02214784098, michael.faust@uk-koeln.de
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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 |
20 Jun 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Jun 2015
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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 |
reduction of BMI
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Protection of trial subjects |
Regular visits (see sketch of study plan) during the study phase with monitoring of general condition, blood pressure measurement, recording of side effects as well as laboratory checks (blood count, kidney- and liver function tests, blood sugar) during the main visits.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
01 May 2013
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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 |
Germany: 37
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Worldwide total number of subjects |
37
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EEA total number of subjects |
37
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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) |
36
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
The subjects of the study were approached through the following procedures: - Contacting patients of the Polyclinic for Endocrinology, Diabetology and Preventive Medicine of the University Hospital Cologne -Display and flyer in the rooms of the University Hospital Cologne -Newspaper advertisement Thes | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
37 | ||||||||||||||||||||||||
Number of subjects completed |
37 | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Intervention (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 | ||||||||||||||||||||||||
Blinding implementation details |
Computer assisted bock randomization.
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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 |
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Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
Placebo Capsule
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Investigational medicinal product code |
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Other name |
Trade name: P-tablets white 7mm Lichtenstein®
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Pharmaceutical forms |
Capsule, soft
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Routes of administration |
Oral use
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Dosage and administration details |
Starting dose was 1 Capsul. The dose was increased in steps of 1 Capsule to a maximum of 4 Capsules. Ts. The assigned mediation (verum or placebo) was administered in the morning immediately after getting up. From the first dose, the mediation was administered daily for a period of 18 weeks ending with the last dose at final visit
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Arm title
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Verum | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Bromocriptine mesilate
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Investigational medicinal product code |
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Other name |
Bromocritpin ratiopharm (Tradename)
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Pharmaceutical forms |
Capsule
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Routes of administration |
Ocular use
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Dosage and administration details |
Each tablet contains 2.87mg bromocriptine mesilate, corresponding to 2.5 mg bromocriptine, for the preparation in the clinical trial half a tablet of bromocriptine was used for the preparation of a capsule used in the clinical trial.
In the trial the content of half a tablet of bromocriptine 2.5mg was used, giving a dosage of 1.25mg per capsule.
Starting dose was 1.25 mg per day (1 Capsule). The dose was increased in steps of 1.25 mg to a maximum of 5 mg per day (4 Capsules) if tolerated. The assigned mediation (verum or placebo) was administered in the morning immediately after getting up. From the first dose, the mediation was administered daily for a period of 18 weeks ending with the last dose at final visit.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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Reporting group title |
Verum
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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 |
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Reporting group title |
Verum
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Reporting group description |
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End point title |
Change in Body Mass Index | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
23.09.2013 to 30.12.2014
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Statistical analysis title |
Statistic primary endpoint | ||||||||||||
Statistical analysis description |
The primary outcome variable is the change in BMI (difference) from the beginning
to the end of the treatment phase. This is compared between treatment groups using exploratory evaluation techniques and is used to determine an effect for the following confirmatory study. The evaluation of the change within the genotype subgroups, as well as the evaluation of the secondary target parameters, is exploratory.
Giving the number of cases of 15 patients per treatment group, the one-sided significa
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Comparison groups |
Placebo v Verum
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Number of subjects included in analysis |
37
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.45 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
06.05.2013 to 03.06.2015
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18
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Reporting groups
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Reporting group title |
Adverse events in whole study population
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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? Yes | |||
Date |
Amendment |
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04 Jun 2013 |
Adjustment of an exclusion criterion due to an amendment of the summary of product characteristics to the test substance by the drug manufacturers |
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04 Dec 2013 |
Increasing of cases due to high drop-out rate |
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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. | |||
The number of cases in the study was small. The prespecified strata with different genotypes could not be completely filled despite an increase in the total number of subjects included. |