Clinical Trial Results:
ESTUDIO DE LA EFICACIA DE BOSENTAN EN LA MODULACIÓN DE LA RESPUESTA INFLAMATORIA Y DE LA CICATRIZACIÓN EN PACIENTES QUEMADOS
Summary
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EudraCT number |
2010-023822-19 |
Trial protocol |
ES |
Global end of trial date |
30 Jun 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Dec 2021
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First version publication date |
19 Dec 2021
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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 |
bosentan2010
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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 |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano, VHIR, +34 934894779, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Juan Pedro Barret Nerín, VHIR, jpbarret@vhebron.net
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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 |
30 Jun 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jun 2017
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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 |
1. Estudiar el efecto de Bosentan en la modulación de la respuesta inflamatoria en los pacientes quemados
2. Estudiar el efecto de Bosentan en la modulación de la cicatrización de los pacientes quemados
3. Determinar la seguridad del tratamiento con Bosentan en los pacientes quemados
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Protection of trial subjects |
Standard procedures of the burn unit. Tewamenter was used to asses skin cicatrization
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jan 2013
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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 |
Spain: 12
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Worldwide total number of subjects |
12
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EEA total number of subjects |
12
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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) |
12
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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 |
Patients were screened at Burns Unit at Vall Hebron Hospital (Barcelona). A daily assesment of patients was performed. | |||||||||||||||
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 | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bosentan | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Bosentan
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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 |
125 mg orally, daily use
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Arm title
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Control no treatment | |||||||||||||||
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 |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bosentan
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Reporting group description |
- | ||
Reporting group title |
Control no treatment
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Reporting group description |
- |
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End point title |
Percentage burn | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
6 months follow-up
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Statistical analysis title |
Percentage burn | ||||||||||||
Comparison groups |
Bosentan v Control no treatment
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Number of subjects included in analysis |
10
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Days hospitalization | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
60 days follow-up
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Statistical analysis title |
Days at hospital | ||||||||||||
Comparison groups |
Bosentan v Control no treatment
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Number of subjects included in analysis |
10
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
> 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
60 days follow-up
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
22.1
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Reporting groups
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Reporting group title |
Bosentan
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Control no treatment
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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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05 Mar 2013 |
Changes in consent information protocol because of safety issues |
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18 Dec 2013 |
Changes in inclusion criteria |
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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. | |||
Small number of patients preclude from obtaining robust conclusions. However, Bosentan use is safe. |