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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Pittsburgh
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004786

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Resource links provided by NLM:

MedlinePlus related topics: Raynaud's Disease Scleroderma

Drug Information available for: Iloprost

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	199/11876, UPITTS-951019
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004786 History of Changes
Health Authority:	United States: Federal Government

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:

Vasodilator Agents
Raynaud Disease
Peripheral Vascular Diseases
Skin Diseases
Hematologic Agents
Vascular Diseases
Sclerosis
Cardiovascular Agents
Pharmacologic Actions

Iloprost
Pathologic Processes
Therapeutic Uses
Connective Tissue Diseases
Scleroderma, Diffuse
Scleroderma, Systemic
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009