NCT00707187

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
Last Updated

June 30, 2008

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

June 25, 2008

Last Update Submit

June 27, 2008

Conditions

Systemic Sclerosis

Keywords

systemic sclerosissclerodermaraynaud phenomenon

Outcome Measures

Primary Outcomes (1)

  • Number of Raynaud attacks

    16 weeks

Study Arms (2)

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

CialisDRUG

35 pills of study medication (20 mg)

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMDNJ

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Scleroderma, SystemicScleroderma, DiffuseRaynaud Disease

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesLivedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, Vascular

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 30, 2008

Study Start

July 1, 2001

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

June 30, 2008

Record last verified: 2008-06

Locations

US(1)