- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183779
PORH and Response to Cold in Raynaud's Phenomenon. (REFRAIN)
Rôle Des Acides Epoxy-eicosatriénoïques et du Monoxyde d'Azote Dans l'hyperhémie Post-occlusive cutanée Digitale et la réponse cutanée au Froid Dans le phénomène de Raynaud Primaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (EETs) and NO during cutaneous post-occlusive hyperemia differs between patients with Raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and L-NMMA at the dorsal side of the fingers.
Healthy controls and patients will undergo 3 visits
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Luc CRACOWSKI, MD-PhD
- Phone Number: +33476769260
- Email: JLCracowski@chu-grenoble.fr
Study Contact Backup
- Name: Matthieu ROUSTIT, PharmD-PhD
- Phone Number: +33476769260
- Email: MRoustit@chu-grenoble.fr
Study Locations
-
-
-
GRENOBLE cedex9, France, 38043
- Recruiting
- Centre d'investigation clinique CIC1406
-
Contact:
- Jean-Luc CRACOWSKI, MD-PhD
- Phone Number: 33476769260
- Email: JLCracowski@chu-grenoble.fr
-
Contact:
- PARIS Adeline, PharmD-PhD
- Phone Number: 33476767383
- Email: AParis@chu-grenoble.fr
-
Principal Investigator:
- Jean-Luc CRACOWSKI, MD-PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Neither raynaud's phenomenon or chronic disease for healthy volunteers
- Raynaud's phenomenon without connective tissue disease for patients in the group "Raynaud"
Exclusion Criteria:
- History of axillary dissection , trauma or surgery
- History of thromboembolic disease or thrombophilia
- Minor or law-protected major
- Exclusion period in another study
- No affiliation to medicare
- Pregnant, parturient or breasting woman
- Concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
- Smoking in the 6 last months
- Person deprived of liberty by a legal or administrative decision, person under legal protection
- Maximal annual indemnification reached.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reynaud
patients with reynaud phenomena
|
|
Experimental: Healthy
Healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post occlusive hyperemia amplitude
Time Frame: day 1
|
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
post occlusive hyperemia amplitude with anesthetic treatment
Time Frame: day1
|
post-occlusive hyperemia amplitude (maximal amplitude in % of maximal vasodilatation and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) treated with anesthetic
|
day1
|
cold-induced vasoconstriction amplitude
Time Frame: day 2
|
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection)
|
day 2
|
cold-induced vasoconstriction amplitude with anesthetic treatment
Time Frame: day 2
|
cold-induced vasoconstriction amplitude (maximal amplitude in % of basal and AUC) in sites NaCl, fluconazole and L-NMMA (intradermal microinjection) with anesthetic local treatment
|
day 2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Luc CRACOWSKI, MD-PhD, INSERM + University Hospital Grenoble
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Peripheral Vascular Diseases
- Hyperemia
- Raynaud Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluconazole
Other Study ID Numbers
- DCIC 14 02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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