Phase 3
N=116
Bosentan in Digital Ulcers
Digital Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00319696 ↗Enrolled (actual)
116
Serious AEs
38.8%
Results posted
Aug 2012
Primary outcome: Primary: Time to Complete Healing of Each Baseline DU
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bosentan 62.5 mg (Drug); Bosentan 125 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Complete Healing of Each Baseline DU |
— | — |
| PRIMARY Time to Complete Healing of Each New DU |
— | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Dressing |
-0.3; -0.2; -0.1; -0.1; -0.1 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Arising |
0.0; -0.0; 0.1; 0.1; 0.1 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Eating |
-0.2; -0.1; -0.2; -0.1; -0.1 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Walking |
-0.1; 0.0; 0.1; 0.1; 0.1 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Hygiene |
-0.0; -0.0; -0.0; 0.1; 0.2 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Reach |
-0.1; 0.0; 0.0; 0.1; 0.0 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Grip |
-0.1; -0.2; -0.1; -0.1; -0.1 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in Scleroderma Health Assessment Questionnaire (SHAQ) Individual Domain Score: Activity |
-0.2; -0.1; -0.1; -0.1; -0.1 | — |
| PRIMARY Mean Changes From Baseline at Each 16 Week Interval up to Week 80 in Overall Hand Pain Related to Finger Ulcers |
-21.59; -28.16; -21.90; -22.96; -24.29 | — |
| PRIMARY Mean Change From Baseline at Each 16 Week Interval up to Week 80 in the UK Systemic Sclerosis Functional Score (UKFS) |
-1.37; -1.25; -0.89; -1.17; -0.45 | — |
| PRIMARY Total Number of New Digital Ulcers (DUs) Per Patient Observed by the Investigator at Planned Visits |
85; 29; 17; 6; 4; 3 | — |
| SECONDARY Adverse Events up to 24 Hours After Last Study Medication |
111 | — |
| SECONDARY Adverse Events Leading to Permanent Discontinuation of the Study Medication |
36 | — |
| SECONDARY Serious Adverse Events up to 28 Days After Last Study Medication |
45 | — |
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 Criteria
- 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 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00319696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.