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Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma (RAPIDS-2)

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ClinicalTrials.gov Identifier: NCT00077584
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.

Condition or disease Intervention/treatment Phase
Digital Ulcers Systemic Sclerosis Drug: Bosentan 62.5 mg Drug: Bosentan 125 mg Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : October 2003
Primary Completion Date : March 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Bosentan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bosentan
The patients received bosentan 62.5 mg twice daily (b.i.d.) for 4 weeks and then 125 mg b.i.d. for 20 weeks
Drug: Bosentan 62.5 mg
Oral tablets containing 62.5 mg of bosentan
Other Name: Ro 47-0203
Drug: Bosentan 125 mg
Oral tablets containing 125 mg of bosentan
Other Name: Ro 47-0203
Placebo Comparator: Placebo
The patients received the matching placebo for 24 weeks
Drug: Placebo
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets


Outcome Measures

Primary Outcome Measures :
  1. Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks [ Time Frame: 24 weeks ]
  2. Total number of new digital ulcers per patient up to Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline to Week 24 in hand pain [ Time Frame: Baseline and Week 24 ]
    Pain assessed on visual analog scales

  2. Change from baseline to Week 24 in hand disability [ Time Frame: Baseline and Week 24 ]
    Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)

  3. Proportion of subjects with treatment-emergent adverse events [ Time Frame: up to 32 weeks (8 week post-treatment follow-up) ]
  4. Proportion of subjects with liver function abnormalities [ Time Frame: Every 4 weeks up to Week 24 ]
    Increase in aminotransferases


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077584


  Hide Study Locations
Locations
United States, Alabama
Barri Fessler, MD
Birmingham, Alabama, United States, 35249-7201
United States, California
Daniel Furst, MD
Los Angeles, California, United States, 90095-1670
United States, Colorado
David Collier, MD
Aurora, Colorado, United States, 80010
United States, Connecticut
Naomi Rothfield, MD
Farmington, Connecticut, United States, 06030-1310
United States, Illinois
Michael Ellman, MD
Chicago, Illinois, United States, 60637
United States, Louisiana
Mittie Doyle, MD
New Orleans, Louisiana, United States, 70112
United States, Maryland
Frederick Wigley, MD
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Joseph Korn, MD
Boston, Massachusetts, United States, 02118-2394
United States, Michigan
Richard Martin, MD
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Thomas Osborn, MD
Rochester, Minnesota, United States, 55905
United States, New Jersey
Vivien Hsu, MD
New Brunswick, New Jersey, United States, 08903
United States, New York
Lee Shapiro, MD
Albany, New York, United States, 12206
Avram Goldberg, MD
Manhasset, New York, United States, 11030
United States, Ohio
Bashar Kahaleh, MD
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Chris Derk, MD
Philadelphia, Pennsylvania, United States, 19107
Thomas Medsger, MD
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Edwin Smith, MD
Charleston, South Carolina, United States, 29425
United States, Texas
Maureen Mayes, MD
Houston, Texas, United States, 77030
United States, Washington
Jerry Molitor, MD
Seattle, Washington, United States, 98101
Howard Kenney, MD
Spokane, Washington, United States, 99204
United States, Wisconsin
Mary Ellen Csuka, MD
Milwaukee, Wisconsin, United States, 53211
Canada, Ontario
Janet Pope, MD
London, Ontario, Canada, N6A 4V2
Peter Lee, MD
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Eric Rich, MD
Montreal, Quebec, Canada, H2L 4M1
Murray Baron, MD
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Actelion
Investigators
Principal Investigator: James Seibold, MD Robert Wood Johnson Medical School, New Brunswick, NJ, USA
More Information

Publications:
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00077584     History of Changes
Obsolete Identifiers: NCT02800993
Other Study ID Numbers: AC-052-331
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Ulcer
Skin Ulcer
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action