Effect of Oral Sildenafil With Digital Therapeutic Iontop... | NCT00710099

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

NCT00710099

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Oct 6, 2011Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

sildenafil
nitroprussiate iontophoresis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jul 2, 2008

First Submission Date that Met QC Criteria

Jul 3, 2008

First Posted Date

Jul 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2011

Last Update Posted Date

Oct 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: sildenafil
2	Active Comparator	SNP iontophoresis	Drug: nitroprussiate iontophoresis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sildenafil	Drug	systemic absorption of sildenafil	1
nitroprussiate iontophoresis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil		one hour

Secondary Outcomes

Measure	Description	Time Frame
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		one hour

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Luc CRACOWSKI, MD	Institut National de la Santé Et de la Recherche Médicale, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Researsh Centre		Grenoble	Isere	38043	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16876881	Background	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.

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013450	Sulfones
D013457