Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Scleroderma Patients
This study has been completed.
Sponsor:
Actelion
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00077584
First received: February 10, 2004
Last updated: February 11, 2010
Last verified: February 2010
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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
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 |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00077584
Show 25 Study Locations
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:
|
Scleroderma, Diffuse Scleroderma, Systemic Connective Tissue Diseases Skin Diseases Bosentan |
Antihypertensive Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015