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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00004786 |
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Date of registration:
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24/02/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
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Scientific title:
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Date of first enrolment:
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December 1995 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00004786 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Contacts
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Name:
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Thomas A. Medsger, Jr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College
of Rheumatology diagnostic criteria
- At least 6 Raynaud's attacks per week
--Prior/Concurrent Therapy--
- No prior participation in oral iloprost study
- At least 4 weeks since participation in other investigational drug studies
- At least 2 months since prostanoid therapy
- At least 12 months since sympathectomy of upper limb
- Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy
discontinued at entry
--Patient Characteristics--
Hematopoietic: No platelet disorder
Hepatic: No bleeding diathesis
Renal: Creatinine clearance (estimated) at least 30 mL/min
Cardiovascular:
No unstable angina pectoris
None of the following within 3 months:
- Stroke
- Transient ischemic attack
- Myocardial infarction
Other:
- No active cancer or other uncontrolled disease
- No current history of alcohol or drug abuse
- No mental disorder precluding compliance
- No pregnant or nursing women
- Negative pregnancy test required of fertile women
- Adequate contraception required of fertile women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Raynaud Disease
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Intervention(s)
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Drug: iloprost
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Secondary ID(s)
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199/11876
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UPITTS-951019
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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