Bosentan in Digital Ulcers

NCT ID: NCT00319696

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-08
• Study Completion Date: 2009-01-22

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).

Conditions

Digital Ulcers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bosentan

Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter

Group Type: EXPERIMENTAL

Bosentan 62.5 mg

Intervention Type: DRUG

Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)

Bosentan 125 mg

Intervention Type: DRUG

Bosentan 125-mg oral tablets administered b.i.d. (target dose)

Interventions

Bosentan 62.5 mg

Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)

Intervention Type: DRUG

Bosentan 125 mg

Bosentan 125-mg oral tablets administered b.i.d. (target dose)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with SSc according to the classification criteria of the American College of Rheumatology

2. SSc patients with at least one DU at baseline qualifying as a CU (see definition section 3.2.2)

3. 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

4. Male or female patients >/= 18 years of age

5. 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

6. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile

7. Signed informed consent.

Exclusion Criteria

1. DUs due to condition other than SSc

2. Severe PAH (WHO class III and IV)

3. Systolic blood pressure < 85 mmHg

4. Hemoglobin concentration < 75% of the lower limit of the normal range

5. AST and/or ALT values greater than 3 times the upper limit of normal

6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C

7. Severe malabsorption or any severe organ failure (e.g., lung, kidney) or any life-threatening condition

8. Pregnancy or breast-feeding

9. Previous treatment with bosentan

10. Treatment with any of the following: glibenclamide (glyburide), fluconazole, cyclosporine A, tacrolimus and any other calcineurin inhibitor 1 week prior to randomization

11. Local injection of botulinum toxin in an affected finger 1 month prior to randomization

12. Treatment with parenteral prostanoids (prostaglandin E, epoprostenol, treprostinil sodium or other prostacyclin analogs) 3 months prior to randomization

13. Treatment with inhaled or oral prostanoids one month prior to randomization

14. Systemic antibiotics to treat infection of DUs 2 weeks prior to randomization

15. Treatment with phosphodiesterase inhibitors such as sildenafil, except for intermittent treatment of male erectile dysfunction

16. Body weight < 40 kg

17. Patient with conditions that prevent compliance with the protocol or adhering to therapy

18. Patient who received an investigational product within 1 month preceding screening

19. Known hypersensitivity to bosentan or any of the excipients.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

AC-052-333

Identifier Type: -

Identifier Source: org_study_id