A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00725361
• Date of registration: 28/07/2008
• Prospective Registration: No
• Primary sponsor: Stanford University
• Public title: A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
• Scientific title: A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.
• Date of first enrolment: June 2008
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00725361
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Lorinda S Chung
• Affiliation: Stanford University

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

n Ulcer

Scleroderma, Systemic

Intervention(s)

Drug: Ambrisentan

Primary Outcome(s)

New Digital Ulcers (DU) 4 Weeks Prior to Week 24 [Time Frame: 4 weeks prior to week 24]

Secondary Outcome(s)

Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline. [Time Frame: 24 weeks]

Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12. [Time Frame: 12 weeks]

New DU 4 Weeks Prior to Week 12 [Time Frame: 4 weeks prior to week 12]

Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12. [Time Frame: 12 weeks]

Secondary ID(s)

IRB Protocol # 14409

SU-07222008-1265

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00725361