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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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Purpose
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 |
|---|---|---|
| Systemic Sclerosis Raynaud Disease | Drug: iloprost | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004786
| Study Chair: | Thomas A. Medsger, Jr. | University of Pittsburgh |
More Information
| ClinicalTrials.gov Identifier: | NCT00004786 History of Changes |
| Other Study ID Numbers: |
199/11876 UPITTS-951019 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
Keywords provided by Office of Rare Diseases (ORD):
|
Raynaud's syndrome arthritis & connective tissue diseases cardiovascular and respiratory diseases rare disease systemic sclerosis |
Additional relevant MeSH terms:
|
Sclerosis Scleroderma, Systemic Scleroderma, Diffuse Raynaud Disease Pathologic Processes Connective Tissue Diseases Skin Diseases |
Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Iloprost Platelet Aggregation Inhibitors Vasodilator Agents |
ClinicalTrials.gov processed this record on June 27, 2017