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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00707187
Recruitment Status : Completed
First Posted : June 30, 2008
Last Update Posted : June 30, 2008
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey

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

Condition or disease Intervention/treatment Phase
Systemic Sclerosis Drug: Cialis Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Double-Blind, Cross-Over Trial of the Efficacy and Safety of IC351 in Female Patients With Raynaud Phenomenon and Female Sexual Dysfunction Secondary to Systemic Sclerosis
Study Start Date : July 2001
Estimated Primary Completion Date : July 2002
Estimated Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
Drug: Cialis
35 pills of study medication (20 mg)
Experimental: 2
35 placebo pills followed with 35 study medication (20 mg)
Drug: Cialis
35 pills of study medication (20 mg)



Primary Outcome Measures :
  1. Number of Raynaud attacks [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707187


Locations
United States, New Jersey
UMDNJ
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey

Responsible Party: James R. Seibold, Professor and Director, UMDNJ
ClinicalTrials.gov Identifier: NCT00707187     History of Changes
Other Study ID Numbers: 0220013701
First Posted: June 30, 2008    Key Record Dates
Last Update Posted: June 30, 2008
Last Verified: June 2008

Keywords provided by Rutgers, The State University of New Jersey:
systemic sclerosis
scleroderma
raynaud phenomenon

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Raynaud Disease
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents