DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Sclerosis; Raynaud Disease

Intervention: iloprost (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Center for Research Resources (NCRR)

Official(s) and/or principal investigator(s):
Thomas A. Medsger, Jr., Study Chair, Affiliation: University of Pittsburgh

Summary

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

Clinical Details

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 1995
Last updated: June 23, 2005

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017