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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

OBJECTIVES:

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Sclerosis Raynaud Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Raynaud's syndrome arthritis & connective tissue diseases cardiovascular and respiratory diseases rare disease systemic sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iloprost

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas A. Medsger, Jr.

Role: STUDY_CHAIR

University of Pittsburgh

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UPITTS-951019

Identifier Type: -

Identifier Source: secondary_id

199/11876