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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004786
Other study ID # 199/11876
Secondary ID UPITTS-951019
Status Completed
Phase Phase 3
First received February 24, 2000
Last updated June 23, 2005
Start date December 1995

Study information

Verified date December 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

OBJECTIVES:

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
iloprost


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Pittsburgh
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