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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Pittsburgh |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004786 |
OBJECTIVES:
I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
Condition | Intervention | Phase |
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Systemic Sclerosis Raynaud Disease |
Drug: iloprost |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 200 |
Study Start Date: | December 1995 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--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:
Other:
Study ID Numbers: | 199/11876, UPITTS-951019 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004786 History of Changes |
Health Authority: | United States: Federal Government |
Raynaud's syndrome arthritis & connective tissue diseases cardiovascular and respiratory diseases rare disease systemic sclerosis |
Vasodilator Agents Raynaud Disease Peripheral Vascular Diseases Skin Diseases Respiration Disorders Rare Diseases Vascular Diseases Sclerosis Cardiovascular Agents |
Iloprost Arthritis Neoplasm Metastasis Connective Tissue Diseases Scleroderma, Diffuse Scleroderma Platelet Aggregation Inhibitors Scleroderma, Systemic |
Vasodilator Agents Raynaud Disease Peripheral Vascular Diseases Skin Diseases Hematologic Agents Vascular Diseases Sclerosis Cardiovascular Agents Pharmacologic Actions |
Iloprost Pathologic Processes Therapeutic Uses Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Cardiovascular Diseases Platelet Aggregation Inhibitors |