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: December 9, 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:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma

Drug Information available for: Iloprost

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma

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

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:	December 9, 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:


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

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