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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:
Collaborator:
University of Pittsburgh
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004786
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
History of Changes

February 24, 2000
June 23, 2005
December 1995
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Complete list of historical versions of study NCT00004786 on ClinicalTrials.gov Archive Site
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Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
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OBJECTIVES:

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

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.
Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
  • Systemic Sclerosis
  • Raynaud Disease
Drug: iloprost
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004786
199/11876, UPITTS-951019
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National Center for Research Resources (NCRR)
University of Pittsburgh
Study Chair: Thomas A. Medsger, Jr. University of Pittsburgh
Office of Rare Diseases (ORD)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP