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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00710099
First received: July 2, 2008
Last updated: October 5, 2011
Last verified: October 2011
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 ]

Secondary Outcome Measures:
  • To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger [ Time Frame: one hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: sildenafil
systemic absorption of sildenafil
Active Comparator: 2
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

Locations
France
Clinical Researsh Centre
Grenoble, Isere, France, 38043
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:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00710099     History of Changes
Other Study ID Numbers: DCIC/08/08
Study First Received: July 2, 2008
Last Updated: October 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
iontophoresis
cutaneous microcirculation
sildenafil
Healthy volunteers

Additional relevant MeSH terms:
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013