Trial of IC351 in Female Scleroderma Patients With Raynau... | NCT00707187

Studies
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

NCT00707187

Sponsor

University of Medicine and Dentistry of New Jersey

Status

Completed

Last Update Posted

Jun 30, 2008Estimated

Enrollment

120Actual

Phase

Phase 2

Conditions

Systemic Sclerosis

Interventions

Cialis

Countries

United States

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

Jun 2008

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 2001

Primary Completion Date

Jul 2002

Completion Date

Jul 2002

First Submitted Date

Jun 25, 2008

First Submission Date that Met QC Criteria

Jun 27, 2008

First Posted Date

Jun 30, 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

Jun 27, 2008

Last Update Posted Date

Jun 30, 2008Estimated

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

Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma

Detailed Description

Not provided

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	35 doses of study medication, IC 351 (20 mg) -- crossover to placebo	Drug: Cialis
2	Experimental	35 placebo pills followed with 35 study medication (20 mg)	Drug: Cialis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cialis	Drug	35 pills of study medication (20 mg)	1 2

Measure	Description	Time Frame
Number of Raynaud attacks		16 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female with diagnosis of scleroderma
Stable sexual relationship with male partner or be sexually active
Raynaud phenomenon at least 6 times per week
Willing to attempt sexual activity 1/month during study period

Exclusion Criteria:

Severe internal organ problems related to scleroderma
Other gynecologic problems
Serious depression
Receiving other experimental and Raynaud treatments

Accepts Healthy Volunteers

Sex

Female

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMDNJ		New Brunswick	New Jersey	08903	United States

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic
D045743	Scleroderma, Diffuse
D011928	Raynaud Disease

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases
D000090122	Livedoid Vasculopathy

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068581	Tadalafil

Ancestor Terms

ID	Term
D002243	Carbolines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided