Status:
COMPLETED
Bosentan in Digital Ulcers
Lead Sponsor:
Actelion
Conditions:
Digital Ulcers
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).
Eligibility Criteria
Inclusion
- Patients with SSc according to the classification criteria of the American College of Rheumatology
- SSc patients with at least one DU at baseline qualifying as a CU (see definition section 3.2.2)
- CU occurred \< 3 months and \> 1 week prior to randomization. The subset of patients with SSc felt to be at high risk for DUs will be identified in the screening period but will not be eligible for enrollment until a CU has developed
- Male or female patients \>/= 18 years of age
- Women of childbearing potential must have a negative pre-treatment pregnancy test and use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination
- Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
- Signed informed consent.
Exclusion
- DUs due to condition other than SSc
- Severe PAH (WHO class III and IV)
- Systolic blood pressure \< 85 mmHg
- Hemoglobin concentration \< 75% of the lower limit of the normal range
- AST and/or ALT values greater than 3 times the upper limit of normal
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- Severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition
- Pregnancy or breast-feeding
- Previous treatment with bosentan
- Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization
- Local injection of botulinum toxin in an affected finger 1 month prior to randomization
- Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization
- Treatment with inhaled or oral prostanoids one month prior to randomization
- Systemic antibiotics to treat infection of DUs 2 weeks prior to randomization
- Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction
- Body weight \< 40 kg
- Patient with conditions that prevent compliance with the protocol or adhering to therapy
- Patient who received an investigational product within 1 month preceding screening
- Known hypersensitivity to bosentan or any of the excipients.
Key Trial Info
Start Date :
July 8 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2009
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00319696
Start Date
July 8 2004
End Date
January 22 2009
Last Update
February 4 2025
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