NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 3

Sponsor: Actelion

Conditions: Digital Ulcers, Systemic Sclerosis

Interventions: Bosentan 62.5 mg, Bosentan 125 mg, Placebo

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.