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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00077584
First received: February 10, 2004
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Digital Ulcers
Systemic Sclerosis
Drug: Bosentan 62.5 mg
Drug: Bosentan 125 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Total number of new digital ulcers per patient up to Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Week 24 in hand pain [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Pain assessed on visual analog scales

  • Change from baseline to Week 24 in hand disability [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Hand disability indexed assessed using the Health Assessment Questionaire (HAQ)

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


Enrollment: 188
Study Start Date: October 2003
Study Completion Date: May 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: 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 
Study First Received: February 10, 2004
Last Updated: October 26, 2016
Health Authority: Switzerland: Swissmedic
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

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

ClinicalTrials.gov processed this record on December 07, 2016