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

National Center for Research Resources (NCRR)

Status and phase

Completed

Phase 3

Conditions

Systemic Sclerosis

Raynaud Disease

Treatments

Drug: iloprost

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00004786

199/11876

UPITTS-951019

Details and patient eligibility

About

OBJECTIVES:

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: