Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

February 10, 2004

Last Updated Date

January 29, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Time to complete healing of the cardinal ulcer up to week 24 whose healing is maintained for 12 weeks
Total number of new digital ulcers per patient up to week 24

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00077584 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hand functionality and pain
Tolerability and safety

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Effect of Bosentan on Healing and Prevention of Ischemic Digital Ulcers in Patients With Systemic Sclerosis

Brief Summary

To date, one clinical trial, RAPIDS-1, was performed in Scleroderma patients with or without digital ulcers at baseline. The RAPIDS-1 study results showed that Bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of this trial is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24 week treatment period.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Systemic Sclerosis
Scleroderma

Intervention ^ICMJE

Drug: Bosentan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

180

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Main Inclusion Criteria:

Systemic Sclerosis (SSc), diffuse or limited
SSc patients with at least one digital ulcer at baseline qualifying as a cardinal ulcer.

Main Exclusion Criteria:

Digital ulcers due to conditions other than SSc.
Severe pulmonary arterial hypertension (PAH) (Who class III and IV).
Malabsorption or any severe organ failure (e.g., lung, kidney, liver) or any life- threatening condition.
Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, or prostacyclin analogs) during the past 3 months prior to randomization.
Treatment with inhaled or oral prostanoids one month prior to randomization.
Previous treatment with bosentan.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00077584

Responsible Party

Study ID Numbers ^ICMJE

RAPIDS-2 / AC-052-331

Study Sponsor ^ICMJE

Actelion

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Carol M. Black, MD	Royal Free Hospital, Centre for Rheumatology, London, UK
Principal Investigator:	Daniel Furst, MD	UCLA School of Medicine, Los Angeles, CA, USA
Principal Investigator:	Joseph H. Korn, MD	Boston University School of Medicine, Boston, MA, USA
Principal Investigator:	Marco Matucci, MD	Universita Degli Studi, E Terapia Medica IV, Florence, Italy
Principal Investigator:	Maureen Mayes, MD	University of Texas, Medical Branch, 6431 Fannin Street, Houston, TX, USA
Principal Investigator:	James Seibold, MD	Robert Wood Johnson Medical School, New Brunswick, NJ, USA

Information Provided By

Actelion

Verification Date

January 2009

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