Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT00004786|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis Raynaud Disease||Drug: iloprost||Phase 3|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and digital cutaneous ulcers.
Patients receive oral iloprost or placebo twice daily for 6 weeks. Thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. Concurrent therapy with angiotensin-converting enzyme inhibitors for Raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed.
Patients are followed at 2 and 6 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Study Start Date :||December 1995|
U.S. FDA Resources
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): NCT00004786
|Study Chair:||Thomas A. Medsger, Jr.||University of Pittsburgh|