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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

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.