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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00077584
Other study ID # AC-052-331
Secondary ID
Status Completed
Phase Phase 3
First received February 10, 2004
Last updated October 26, 2016
Start date October 2003
Est. completion date May 2005

Study information

Verified date October 2016
Source Actelion
Contact n/a
Is FDA regulated No
Health authority Switzerland: SwissmedicUnited States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: The Italian Medicines AgencySpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
Study type Interventional

Clinical Trial 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.


Other known NCT identifiers
  • NCT02800993

Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date May 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Bosentan 62.5 mg
Oral tablets containing 62.5 mg of bosentan
Bosentan 125 mg
Oral tablets containing 125 mg of bosentan
Placebo
Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Locations

Country Name City State
Canada Janet Pope, MD London Ontario
Canada Eric Rich, MD Montreal Quebec
Canada Murray Baron, MD Montreal Quebec
Canada Peter Lee, MD Toronto Ontario
United States Lee Shapiro, MD Albany New York
United States David Collier, MD Aurora Colorado
United States Frederick Wigley, MD Baltimore Maryland
United States Barri Fessler, MD Birmingham Alabama
United States Joseph Korn, MD Boston Massachusetts
United States Edwin Smith, MD Charleston South Carolina
United States Michael Ellman, MD Chicago Illinois
United States Naomi Rothfield, MD Farmington Connecticut
United States Richard Martin, MD Grand Rapids Michigan
United States Maureen Mayes, MD Houston Texas
United States Daniel Furst, MD Los Angeles California
United States Avram Goldberg, MD Manhasset New York
United States Mary Ellen Csuka, MD Milwaukee Wisconsin
United States Vivien Hsu, MD New Brunswick New Jersey
United States Mittie Doyle, MD New Orleans Louisiana
United States Chris Derk, MD Philadelphia Pennsylvania
United States Thomas Medsger, MD Pittsburgh Pennsylvania
United States Thomas Osborn, MD Rochester Minnesota
United States Jerry Molitor, MD Seattle Washington
United States Howard Kenney, MD Spokane Washington
United States Bashar Kahaleh, MD Toledo Ohio

Sponsors (1)

Lead Sponsor Collaborator
Actelion

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Matucci-Cerinic M, Denton CP, Furst DE, Mayes MD, Hsu VM, Carpentier P, Wigley FM, Black CM, Fessler BJ, Merkel PA, Pope JE, Sweiss NJ, Doyle MK, Hellmich B, Medsger TA Jr, Morganti A, Kramer F, Korn JH, Seibold JR. Bosentan treatment of digital ulcers re — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to complete healing of the cardinal ulcer (CU) up to Week 24 in patients with CU healing maintained for 12 weeks 24 weeks No
Primary Total number of new digital ulcers per patient up to Week 24 24 weeks No
Secondary Change from baseline to Week 24 in hand pain Pain assessed on visual analog scales Baseline and Week 24 No
Secondary Change from baseline to Week 24 in hand disability Hand disability indexed assessed using the Health Assessment Questionaire (HAQ) Baseline and Week 24 No
Secondary Proportion of subjects with treatment-emergent adverse events up to 32 weeks (8 week post-treatment follow-up) Yes
Secondary Proportion of subjects with liver function abnormalities Increase in aminotransferases Every 4 weeks up to Week 24 Yes
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