Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers - Full Text View

Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers (INFLUX-VS)

This study is currently recruiting participants.

Verified by University Hospital, Grenoble, July 2009

First Received: July 2, 2008 Last Updated: July 2, 2009 History of Changes

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00710099

Purpose

Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Condition	Intervention
Healthy	Drug: sildenafil Drug: nitroprussiate iontophoresis

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment
Official Title:	Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil [ Time Frame: one hour ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: sildenafil systemic absorption of sildenafil
2: Active Comparator SNP iontophoresis	Drug: nitroprussiate iontophoresis nitroprussiate iontophoresis

Detailed Description:

The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age over 18
No significant medical history

Exclusion Criteria:

Age under 18
Period of exclusion for an other study
Pregnancy
Breast feeding
Severe disease
Cigarette smoking

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710099

Contacts

Contact: Jean-Luc CRACOWSKI, MD

+33(0)476769260

JLCracowski@chu-grenoble.fr

Locations

France, Isere
Clinical Researsh Centre	Recruiting
Grenoble, Isere, France, 38043
Contact: Jean-Luc Cracowski, MD +330476769260
Principal Investigator: Jean-Luc Cracowski, MD
Sub-Investigator: Blaise Sophie, MD

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator:

Jean-Luc CRACOWSKI, MD

Institut National de la Santé Et de la Recherche Médicale, France

More Information

Publications:

Cracowski JL, Minson CT, Salvat-Melis M, Halliwill JR. Methodological issues in the assessment of skin microvascular endothelial function in humans. Trends Pharmacol Sci. 2006 Sep;27(9):503-8. Epub 2006 Jul 31. Review.

Responsible Party:	Clinical research management ( M Eric Svhan )
Study ID Numbers:	DCIC/08/08
Study First Received:	July 2, 2008
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00710099 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

iontophoresis
cutaneous microcirculation
sildenafil
Healthy volunteers

Study placed in the following topic categories:

Vasodilator Agents
Phosphodiesterase Inhibitors
Sildenafil
Cardiovascular Agents
Healthy

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009