Clinical Trial Results:
The effect of curcumin and genistein in CF patients with a class III mutation
Summary
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EudraCT number |
2014-000817-30 |
Trial protocol |
NL |
Global end of trial date |
08 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Mar 2020
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First version publication date |
11 Mar 2020
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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 |
TICTAC-2014
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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 |
UMC Utrecht
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Sponsor organisation address |
Lundlaan 6, Utrecht, Netherlands,
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Public contact |
Prof. dr. C.K. van der Ent, University Medical Center Utrecht, 0031 (0)887553201, k.vanderent@umcutrecht.nl
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Scientific contact |
Gitte Berkers, University Medical Center Utrecht, 0031 (0)887553741, g.berkers-3@umcutrecht.nl
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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 Nov 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 May 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
08 May 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 |
Curcumin and genistein might be a cheap alternative for treating patients with a class III gating mutation
Main objective of the trial is to investigate the clinical response on treatment with curcumin and genistein in CF-patients with a class III S1251N mutation.
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Protection of trial subjects |
N.A.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Sep 2014
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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 |
Netherlands: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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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) |
4
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Adolescents (12-17 years) |
4
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Adults (18-64 years) |
5
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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 |
- | |||||||||
Pre-assignment
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Screening details |
inclusion criteria: • CFTR genotype compound/ S1251N • Already had a rectal biopsy to produce an organoid • Male and female patients, aged 6 years or older on the date of informed consent or, where appropriate, date of assent • Signed informed consent form (IC), and where appropriate, signed assent form | |||||||||
Period 1
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Period 1 title |
treatment period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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Treatment | |||||||||
Arm description |
treatment with curcumin and genistein | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
curcumin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
curcumin was dosed based on the weight of the patient with a minimum dose of 102.9 and maximum dose of 138.5 mg/Kg/day
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Investigational medicinal product name |
genistein
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Dose was based on weight with a minimum dose of 3.3 and a maximum dose of 4.8 mg/Kg/day
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Arm title
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baseline | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
treatment period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Treatment
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Reporting group description |
treatment with curcumin and genistein | ||
Reporting group title |
baseline
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Reporting group description |
- |
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End point title |
Sweat chloride concentration | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
after 8 weeks of treatment
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Statistical analysis title |
Wilcoxon signed rank test | ||||||||||||
Comparison groups |
baseline v Treatment
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Number of subjects included in analysis |
26
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Point estimate |
30
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
18.28 | ||||||||||||
upper limit |
41.72 | ||||||||||||
Variability estimate |
Standard deviation
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Adverse events information
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Timeframe for reporting adverse events |
From the first visit of the trial (t=0) untill the last visit (t= 8weeks)
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
NA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
treatment period
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Reporting group description |
during treatment with curcumin and genistein | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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27 Jun 2014 |
The effect of curcumin and genistein was evaluated but not compared to the effect of Ivacaftor treatment. This was done in a separate trial |
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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 |