Bosentan in Digital Ulcers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00319696
• Date of registration: 27/04/2006
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: Bosentan in Digital Ulcers RAPIDS 2 OL
• Scientific title: Long-term Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers
• Date of first enrolment: July 8, 2004
• Target sample size: 116
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00319696
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Canada, France, Germany, Italy, Switzerland, United Kingdom, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Digital Ulcers

Intervention(s)

Drug: Bosentan 125 mg

Drug: Bosentan 62.5 mg

Primary Outcome(s)

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS) [Time Frame: 80 weeks]

Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits [Time Frame: At planned visits up to week 80]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating [Time Frame: 80 weeks]

Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach [Time Frame: 80 weeks]

Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers [Time Frame: 80 weeks]

Time to Complete Healing of Each Baseline DU [Time Frame: Baseline to healing]

Time to Complete Healing of Each New DU [Time Frame: New DU occurence to healing]

Secondary Outcome(s)

Serious Adverse Events up to 28 Days After Last Study Medication [Time Frame: 80 weeks]

Adverse Events up to 24 Hours After Last Study Medication [Time Frame: 80 weeks]

Adverse Events Leading to Permanent Discontinuation of the Study Medication [Time Frame: 80 weeks]

Secondary ID(s)

AC-052-333

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00319696