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Trial record 10 of 13 for:    PDE-5 inhibitors raynaud's

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

Tracking Information
First Submitted Date  ICMJE June 25, 2008
First Posted Date  ICMJE June 30, 2008
Last Update Posted Date June 30, 2008
Study Start Date  ICMJE July 2001
Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2008)
Number of Raynaud attacks [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Sclerosis
Intervention  ICMJE Drug: Cialis
35 pills of study medication (20 mg)
Study Arms  ICMJE
  • Experimental: 1
    35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
    Intervention: Drug: Cialis
  • Experimental: 2
    35 placebo pills followed with 35 study medication (20 mg)
    Intervention: Drug: Cialis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2008)
120
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2002
Primary Completion Date July 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00707187
Other Study ID Numbers  ICMJE 0220013701
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James R. Seibold, Professor and Director, UMDNJ
Study Sponsor  ICMJE University of Medicine and Dentistry of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rutgers, The State University of New Jersey
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP