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

PHASE3CompletedINTERVENTIONAL

Enrollment

188

Participants

Timeline

Start Date

October 31, 2003

Primary Completion Date

March 31, 2005

Study Completion Date

May 31, 2005

Conditions

Digital UlcersSystemic Sclerosis

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