Clinical Trial Results:
The role of paroxetine in patients taking telaprevir-based HCV therapy: lack of a drug-drug interaction? (ROLEX)
Summary
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EudraCT number |
2012-005372-34 |
Trial protocol |
NL |
Global end of trial date |
15 Sep 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Sep 2019
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First version publication date |
21 Sep 2019
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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 |
UMCN-AKF12.02
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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 |
Radboudumc
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Sponsor organisation address |
Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
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Public contact |
David Burger, Radboud University Medical Centre, 31 243616405,
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Scientific contact |
David Burger, Radboud University Medical Centre, 31 243616405,
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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 |
15 Sep 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Sep 2014
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.
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Protection of trial subjects |
The study will be performed in HCV infected patients who will be treated with telaprevir containing HCV treatment. Patients are already on antidepressant therapy with paroxetine. We chose to conduct this study in this population because these patients will be treated with telaprevir and paroxetine anyway and will be exposed to these drugs in regular care. The burden of participation in the trial is limited. We only perform a minimal change in the standard treatment regimen, since included patients are already on antidepressant thera-py with paroxetine and are eligible for start of a TVR-containing regimen for treatment of their HCV infection. To further limit the burden, study visits are mostly planned in accord-ance with the regular visiting scheme for HCV treatment.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Apr 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 |
Netherlands: 3
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Worldwide total number of subjects |
3
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EEA total number of subjects |
3
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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) |
3
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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 |
At least 18 and not older than 65 years at screening, able and willing to sign the Informed Consent Form prior to screening evaluations, subject has a chronic HCV infection with genotype 1, subject is eligible for telaprevir containing HCV treatment, subject is on a stable dose of 20 mg paroxetine QD for at least 4 weeks. | ||||||||||
Period 1
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Period 1 title |
paroxetine alone
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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paroxetine | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Active comparator | ||||||||||
Investigational medicinal product name |
paroxetine
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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 |
20 mg once daily
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Period 2
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Period 2 title |
paroxetine + telaprevir
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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interaction arm | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
paroxetine
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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 |
20 mg once daily
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Investigational medicinal product name |
telaprevir
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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 |
1125 mg twice daily
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Baseline characteristics reporting groups
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Reporting group title |
paroxetine alone
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
paroxetine
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Reporting group description |
- | ||
Reporting group title |
interaction arm
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Reporting group description |
- |
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End point title |
paroxetine AUC0-24h decrease | |||||||||
End point description |
To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.
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End point type |
Primary
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End point timeframe |
Interaction versus paroxetine alone
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Statistical analysis title |
descriptive | |||||||||
Statistical analysis description |
Individual analysis
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Comparison groups |
paroxetine v interaction arm
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Number of subjects included in analysis |
4
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
< 0.05 | |||||||||
Method |
ANOVA | |||||||||
Parameter type |
geometric mean ratio | |||||||||
Confidence interval |
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level |
90% | |||||||||
sides |
2-sided
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lower limit |
0.8 | |||||||||
upper limit |
2 | |||||||||
Variability estimate |
Standard error of the mean
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Notes [1] - explorative |
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Adverse events information [1]
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Timeframe for reporting adverse events |
entire study
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No (serious)adverse events were reported |
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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? Yes | |||||||
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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 |