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Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
This study has been completed.
Study NCT00077584   Information provided by Actelion
First Received: February 10, 2004   Last Updated: January 29, 2009   History of Changes

February 10, 2004
January 29, 2009
September 2003
 
  • 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
Same as current
Complete list of historical versions of study NCT00077584 on ClinicalTrials.gov Archive Site
  • Hand functionality and pain
  • Tolerability and safety
Same as current
 
Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
  • Systemic Sclerosis
  • Scleroderma
Drug: Bosentan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
180
December 2005
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00077584
 
RAPIDS-2 / AC-052-331
Actelion
 
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
Actelion
January 2009

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