Clinical Trial Results:
Heat-, Cold-, and Mechanical Painthresholds under exposition of high dose topical Capsaicin
Summary
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EudraCT number |
2013-002546-36 |
Trial protocol |
AT |
Global end of trial date |
07 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Oct 2022
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First version publication date |
15 Oct 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 |
CAPS2
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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 |
MedUni Wien
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Sponsor organisation address |
Waehringer Guertel 18-22, Vienna, Austria, 1090
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Public contact |
Investigator, MedUni Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie, 0043 1404004139,
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Scientific contact |
Investigator, MedUni Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie, 0043 1404004139,
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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 |
17 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Dec 2020
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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 |
Determination of heat-painthreshold under exposition of high-dose Capsaicin for 60 minutes
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Protection of trial subjects |
Inclusion criteria were unharmed, unscarred skin on forearms with no neurological malfunction. Exclusion criteria were: pregnancy, breast-feeding, use of capsaicin in the areas of the study treatment or regular use of analgesics within the previous three months as well as any contraindication against at least one of the drug medications, and drug addiction.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Aug 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 |
Austria: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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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) |
20
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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 |
20 volunteers (10 women and 10 men) were enrolled in the study. There mean age was 25 years, range: 21 to 29. All were of white ethnic origin. All the 20 study subjects received patch treatments, completed the study, and were included in the statistical analysis of outcome | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
20 | |||||||||
Number of subjects completed |
20 | |||||||||
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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Placebo | |||||||||
Arm description |
- | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous patch
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Routes of administration |
Topical use
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Dosage and administration details |
0% 1x
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Arm title
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Qutenza | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Qutenza
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cutaneous patch
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Routes of administration |
Epicutaneous use
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Dosage and administration details |
part of one high-concentration (640 μg/cm2 [8%]) capsaicin patch (QutenzaTM, ASTELLAS PHARMA, Tokyo, Japan) of 9 cm² (3x3 cm) was applied for 60 minutes to the distal left or right forearm
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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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Subject analysis sets
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Subject analysis set title |
Pain threshold
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The primary endpoint was the mean heat pain threshold (HPTTSA) at 60 minutes recorded by each participant separately for each of the two application sites.
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Qutenza
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Reporting group description |
- | ||
Subject analysis set title |
Pain threshold
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The primary endpoint was the mean heat pain threshold (HPTTSA) at 60 minutes recorded by each participant separately for each of the two application sites.
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End point title |
heat painthreshold under exposition of high-dose capsaicin for 60 minutes | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
60 minutes
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Statistical analysis title |
ANOVA | ||||||||||||
Comparison groups |
Placebo v Qutenza
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Number of subjects included in analysis |
20
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Analysis specification |
Post-hoc
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Analysis type |
non-inferiority | ||||||||||||
P-value |
< 5 | ||||||||||||
Method |
ANOVA | ||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
19.11.2013-11.04.2014
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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 non-serious adverse events |
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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 |