Clinical Trial Results:
CAPSAICIN PATCH 8% FOR THE TREATMENT OF PERSISTENT PAIN AFTER INGUINAL HERNIOTOMY
Summary
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EudraCT number |
2012-001540-22 |
Trial protocol |
DK |
Global end of trial date |
30 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Aug 2016
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First version publication date |
26 Aug 2016
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Other versions |
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Summary report(s) |
A Capsaicin (8%) Patch in the Treatment of Severe Persistent Inguinal Postherniorrhaphy Pain: A Randomized, Double-Blind, Placebo-Controlled Trial |
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 |
76122012
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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 |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, copenhagen, Denmark,
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Public contact |
Tværfagligt smertecenter, Rigshospitalet, 45 35457612,
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Scientific contact |
Tværfagligt smertecenter, Rigshospitalet, 45 35457612,
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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 Sep 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Sep 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Sep 2013
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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 investigate analgesic and sensory effects of a capsaicin patch (Qutenza) in patients with severe postherniotomy pain and sensory abnormalities in the skin.
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Protection of trial subjects |
Patients were pre-treated with a topical local anesthetic cream (EMLA,
lidocaine/prilocaine 25 mg/25 g, AstraZeneca AB,
Sweden) 60 min before capsaicin patch application.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2012
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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 |
Denmark: 46
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Worldwide total number of subjects |
46
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EEA total number of subjects |
46
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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) |
31
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients eligible in the study were referred to the Multidisciplinary Pain Center by a surgeon or a general practitioner and written informed consent was obtained from all patients. Patients were $18 years with severe unilateral persistent inguinal postherniorrhaphy pain (numerical rating scale [NRS, 0–10] $ 5) for more than 6 months. | |||||||||||||||
Pre-assignment
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Screening details |
Patients eligible in the study were referred to the Multidisciplinary Pain Center by a surgeon or a general practitioner and written informed consent was obtained from all patients. Patients were $18 years with severe unilateral persistent inguinal postherniorrhaphy pain (numerical rating scale [NRS, 0–10] $ 5) for more than 6 months. | |||||||||||||||
Period 1
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Period 1 title |
3 months (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 |
Investigator, Subject, Data analyst, Assessor | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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capsaicin group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
capsaicin patch
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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 |
Cutaneous use
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Dosage and administration details |
capsaicin patch (capsaicin 640 mg/cm2, 8% w/w; Astellas
Pharma Europe B.V., Leiderdorp, The Netherlands)
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Arm title
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placebo group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
inactive placebo patch
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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 |
Cutaneous use
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Dosage and administration details |
inactive placebo patch
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End points reporting groups
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Reporting group title |
capsaicin group
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Reporting group description |
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Reporting group title |
placebo group
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Reporting group description |
- | ||
Subject analysis set title |
placebo group
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
inactive placebo patch
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Subject analysis set title |
capsaicin group
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
capsaicin group
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End point title |
The primary outcome was comparisons of SPIDs between capsaicin and placebo treatments at 1, 2 and 3 months after patch application | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome was comparisons of SPIDs
between capsaicin and placebo treatments at 1, 2 and 3 months
after patch application
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Statistical analysis title |
Linear regression analyses | ||||||||||||
Comparison groups |
capsaicin group v placebo group
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Number of subjects included in analysis |
42
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
At the clinical visit 1month after patch application patients were asked to report if they had experienced application site skin reactions (erythema, pain, burning sensation) or any other adverse events
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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 |
Capsaicin group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||
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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 |