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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2009-015780-14-AT |
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Date of registration:
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12/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of high dose remifentanil on the reversal of established sunburn-induced hyperalgesia in human volunteers - High-Dose-RemiSun
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Scientific title:
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The effect of high dose remifentanil on the reversal of established sunburn-induced hyperalgesia in human volunteers - High-Dose-RemiSun |
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Date of first enrolment:
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28/12/2009 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015780-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Men or women, aged between 19 and 40 years
Body mass index between 15th and 85th percentile
Normal findings in the medical history and physical examination
Drug free for 1 week prior to the study day
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Regular use of medication especially analgesics
Abuse of alcoholic beverages, drug abuse
History of asthma
Participation in a clinical trial in the 2 weeks preceding the study
Symptoms of a clinically relevant illness in the 2 weeks before the first study day
Resting systolic blood pressure >135mmHg or diastolic blood pressure >85mmHg
History of allergy to any of the medications used in the study
Pregnancy or breast feeding
Acute skin diseases like sunburn or skin lesions on the relevant areas and UV sensitive skin conditions, like Xeroderma pigmentosa
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Volunteer study with 24 healthy volunteers to perform pain research and to study the reversal of hyperalgesia by IMP
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Intervention(s)
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Trade Name: Ultiva
Product Name: Remifentanil
Product Code: N01AH06
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Primary end point(s): Area of pin prick hyperalgesia (starting 24 hours after irradiation) until 6 hours after discontinuation of IMP
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Secondary Objective: (SR)-function to a set of rigid von Frey filaments
Mechanical pain threshold within the area of pin prick hyperalgesia
area of dynamic allodynia to brush,
heat pain perception threshold
SR-function to dynamic mechanical stimuli
Superficial blood flow (sBF) in the hyperalgesic area
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Main Objective: To study that sunburn induced mechanical hyperalgesia is reversed by highdose remifentanil. Main outcome variable: area of pin prick hyperalgesia.
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Secondary ID(s)
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High-Dose-RemiSun
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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