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

This study has been completed.
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00077584
First received: February 10, 2004
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Systemic Sclerosis
Scleroderma
Drug: Bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Hand functionality and pain
  • Tolerability and safety

Estimated Enrollment: 180
Study Start Date: September 2003
Study Completion Date: December 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077584

  Show 25 Study Locations
Sponsors and Collaborators
Actelion
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00077584     History of Changes
Other Study ID Numbers: RAPIDS-2 / AC-052-331
Study First Received: February 10, 2004
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
Digital Ulcers
Finger Ulcers
Systemic Sclerosis
Scleroderma

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014