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

This study has been completed.
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001


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
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 200
Study Start Date: December 1995
Detailed 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


No unstable angina pectoris

None of the following within 3 months:

  • Stroke
  • Transient ischemic attack
  • Myocardial infarction


  • 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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004786

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Pittsburgh
Study Chair: Thomas A. Medsger, Jr. University of Pittsburgh
  More Information Identifier: NCT00004786     History of Changes
Other Study ID Numbers: 199/11876
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:
Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Vasodilator Agents processed this record on September 19, 2017