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
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OBJECTIVES:
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 |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | December 1995 |


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Ages Eligible for Study: | 18 Years to 0 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 |
ClinicalTrials.gov Identifier: | NCT00004786 |
Other Study ID Numbers: |
199/11876 UPITTS-951019 |
First Posted: | February 25, 2000 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 2001 |
Raynaud's syndrome arthritis & connective tissue diseases cardiovascular and respiratory diseases rare disease systemic sclerosis |
Raynaud Disease Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Pathologic Processes Connective Tissue Diseases Skin Diseases |
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents |