- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00707187
Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction
June 27, 2008 updated by: University of Medicine and Dentistry of New Jersey
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
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- UMDNJ
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
35 doses of study medication, IC 351 (20 mg) -- crossover to placebo
|
35 pills of study medication (20 mg)
|
Experimental: 2
35 placebo pills followed with 35 study medication (20 mg)
|
35 pills of study medication (20 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Raynaud attacks
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Primary Completion
July 1, 2002
Study Completion
July 1, 2002
Study Registration Dates
First Submitted
June 25, 2008
First Submitted That Met QC Criteria
June 27, 2008
First Posted (Estimate)
June 30, 2008
Study Record Updates
Last Update Posted (Estimate)
June 30, 2008
Last Update Submitted That Met QC Criteria
June 27, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0220013701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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