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

NCT00725361 | Completed Results

• 2 other identifiers: SU-07222008-1265IRB Protocol # 14409
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

n Ulcer; Scleroderma, Systemic

Outcome Measures

Primary Outcomes (1)

• New Digital Ulcers (DU) 4 Weeks Prior to Week 24

  The number of new digital ulcers (DU) that have developed in the preceding 4 weeks assessed at week 24 from baseline.

  4 weeks prior to week 24

Secondary Outcomes (4)

• New DU 4 Weeks Prior to Week 12

  4 weeks prior to week 12

• Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.

  12 weeks

• Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.

  12 weeks

• Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.

  24 weeks

Study Arms (1)

Active

EXPERIMENTAL

Ambrisentan

Drug: Ambrisentan

Interventions

Ambrisentan DRUG

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Lorinda Chung
• Organization: StanfordU

shauwei@stanford.edu

650-736-0727

Study Officials

• Lorinda S Chung

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 31, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-03

Locations

US (1)