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Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers

NCT ID: NCT00710099

Last Updated: 2011-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

sildenafil

Intervention Type DRUG

systemic absorption of sildenafil

2

SNP iontophoresis

Group Type ACTIVE_COMPARATOR

nitroprussiate iontophoresis

Intervention Type DRUG

nitroprussiate iontophoresis

Interventions

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sildenafil

systemic absorption of sildenafil

Intervention Type DRUG

nitroprussiate iontophoresis

nitroprussiate iontophoresis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Luc CRACOWSKI, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Clinical Researsh Centre

Grenoble, Isere, France

Site Status

Countries

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France

References

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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. doi: 10.1016/j.tips.2006.07.008. Epub 2006 Jul 31.

Reference Type BACKGROUND
PMID: 16876881 (View on PubMed)

Other Identifiers

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DCIC/08/08

Identifier Type: -

Identifier Source: org_study_id