NCT00004786

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2001

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Systemic SclerosisRaynaud Disease

Keywords

Raynaud's syndromearthritis & connective tissue diseasescardiovascular and respiratory diseasesrare diseasesystemic sclerosis

Interventions

iloprostDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicRaynaud DiseaseArthritisConnective Tissue DiseasesRespiratory Tract DiseasesRare Diseases

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin DiseasesLivedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularJoint DiseasesMusculoskeletal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Thomas A. Medsger, Jr.

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

December 1, 1995

Last Updated

June 24, 2005

Record last verified: 2001-12