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

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:

Genetics Home Reference related topics: systemic scleroderma

MedlinePlus related topics: Scleroderma

Drug Information available for: Bosentan

Genetic and Rare Diseases Information Center resources: Systemic Scleroderma Localized Scleroderma

U.S. FDA Resources

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 (Adult, Senior)
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


ClinicalTrials.gov Identifier:	NCT00077584 History of Changes
Obsolete Identifiers:	NCT02800993
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 Scleroderma, Localized Pathologic Processes Connective Tissue Diseases	Skin Diseases Bosentan Antihypertensive Agents Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016