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

NCT00077584 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-02-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bosentan 62.5 mg

Oral tablets containing 62.5 mg of bosentan

DRUG

Bosentan 125 mg

Oral tablets containing 125 mg of bosentan

DRUG

Placebo

Oral tablets matching bosentan 62.5-mg tablets and bosentan 125-mg tablets

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • James Seibold, MD · Robert Wood Johnson Medical School, New Brunswick, NJ, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2005-03-31
Completion
2005-05-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00077584 on ClinicalTrials.gov