Clinical Trial Results:
The effects of PXR activation on hepatic fat content
Summary
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EudraCT number |
2014-003422-41 |
Trial protocol |
FI |
Global end of trial date |
01 Feb 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Mar 2022
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First version publication date |
08 Mar 2022
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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 |
Rifa-Stea
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02329405 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Oulu University Hospital
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Sponsor organisation address |
Kajaanintie 50, Oulu, Finland,
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Public contact |
janne.hukkanen@oulu.fi, Oulu University Hospital, Department of Internal Medicine, 358 83156212, janne.hukkanen@oulu.fi
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Scientific contact |
janne.hukkanen@oulu.fi, Oulu University Hospital, Department of Internal Medicine, 358 83156212, janne.hukkanen@oulu.fi
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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 |
Interim
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Date of interim/final analysis |
15 Feb 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Feb 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Feb 2018
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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 study how PXR activation by rifampicin affects hepatic fat content
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Protection of trial subjects |
Basic laboratory measures controlled to ensure safety of using rifampicin.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Nov 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 |
Finland: 17
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Worldwide total number of subjects |
17
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EEA total number of subjects |
17
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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) |
17
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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 |
Healthy volunteers responding to recruitment add in email list. | |||||||||||||||
Pre-assignment
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Screening details |
Healthy volunteers responding to recruitment add in email list. Screened and randomized to two-arm crossover study. | |||||||||||||||
Period 1
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Period 1 title |
Screening and randomization (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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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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Rifampicin arm | |||||||||||||||
Arm description |
Rifampicin 600 mg daily for one week | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Rifampicin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
600 mg daily for a week
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Arm title
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Placebo arm | |||||||||||||||
Arm description |
Placebo daily for a week. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo (contains magnesium stearate, microcrystalline cellulose)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Tablet once daily for a week.
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Baseline characteristics reporting groups
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Reporting group title |
Screening and randomization
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Rifampicin arm
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Reporting group description |
Rifampicin 600 mg daily for one week | ||
Reporting group title |
Placebo arm
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Reporting group description |
Placebo daily for a week. |
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End point title |
Hepatic fat | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
After one-week of rifampicin/placebo
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Statistical analysis title |
Student t-test | ||||||||||||
Comparison groups |
Placebo arm v Rifampicin arm
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Number of subjects included in analysis |
32
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Notes [1] - EudraCT system does not understand crossover analysis, thus, there is only 16 subjects. |
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Adverse events information
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Timeframe for reporting adverse events |
One-week study arms
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.0
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Reporting groups
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Reporting group title |
Rifampicin arm
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo arm
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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 |