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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004786
First Posted: February 25, 2000
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD)
  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
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Pittsburgh
Investigators
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
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: June 24, 2005
Last Verified: December 2001

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
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents