N/A
N=20
A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
n Ulcer · Scleroderma, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT00725361 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Feb 2017
Primary outcome: Primary: New Digital Ulcers (DU) 4 Weeks Prior to Week 24 — 0.06 new digital ulcers
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ambrisentan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Digital Ulcers (DU) 4 Weeks Prior to Week 24 |
0.06 | — |
| SECONDARY New DU 4 Weeks Prior to Week 12 |
-0.26 | — |
| SECONDARY Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12. |
7 | — |
| SECONDARY Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12. |
12 | — |
| SECONDARY Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline. |
-0.06 | — |
Summary
This is a research study of an investigational drug called ambrisentan (Letairis) in the treatment and prevention of digital ulcers in patients with systemic sclerosis.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of limited or diffuse systemic sclerosis (SSc) according to American College of Rheumatology or LeRoy criteria
- Age greater than 18 years of age
- At least one digital ulcer located on the volar or lateral surface at or distal to the proximal interphalangeal joints
- At least one new DU that developed within 12 weeks prior to screening
- Vasodilator therapies, including calcium channel blockers, alpha-1-antagonists, ACE-inhibitors, nitroglycerin, and angiotensin receptor blockers, are permitted as long as the doses are stable for 2 weeks prior to screening and throughout the study
- Treatment with omeprazole or other proton pump inhibitors must be stable for 2 weeks prior to screening and throughout the study
Exclusion Criteria
- Patients with pulmonary arterial hypertension, NYHA Class III or IV
- Patients who are hemodynamically unstable, or have acute renal, cardiac or pulmonary failure
- Concurrent malignancy except non-melanoma skin cancers
- Patients who have required systemic antibiotics for infected digital ulcers within 2 weeks of screening
- Patients receiving phosphodiesterase-5 inhibitors, endothelin receptor antagonists, or prostanoids within 4 weeks of screening
- Patients receiving cyclosporine within 6 weeks of screening
- Patients who have participated in any investigational study within 30 days of screening
- Pregnant or nursing women
- Patients with a history of drug or alcohol abuse within 6 months of screening
- History of hepatitis B, hepatitis C, or HIV infection
- Any medical condition that, in the opinion of the investigator, might interfere with the subject's participation in the study or poses an added risk for the subject
- Inability to comply with study and follow-up procedures
- Transaminase elevation > 3X the upper limit of normal at screening
- Hemoglobin less than 8.5 g/dL
- Platelet count less than 100 X 109/L
- White blood cell count less than 3.0 X 109/L
- Serum creatinine less than 2.0 mg/dL
Data sourced from ClinicalTrials.gov (NCT00725361). 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.