Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: University of Pittsburgh
• Treatments: Iloprost

Criteria

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