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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: n Ulcer; Scleroderma, Systemic

Intervention: Ambrisentan (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Lorinda S Chung, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

Official title: A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

1. The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.

2. The percentage of subjects experiencing complete (total reepithelialization) healing of all baseline DU at weeks 12 and 24.

3. The percentage of subjects experiencing complete healing of > 50% of the number of baseline DU at weeks 12 and 24.

4. Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at weeks 12 and 24.

5. Change in physician global assessment of DU severity by visual analogue scale (VAS) at weeks 12 and 24.

6. Change in the Cochin Hand Functional Scale (CHFS) at weeks 12 and 24.

7. Change in SF-36 assessment of health status at weeks 12 and 24.

8. Change in MRSS at weeks 12 and 24.

Detailed description: Ambrisentan is an endothelin blocker approved for the treatment of pulmonary arterial hypertension. Patients with systemic sclerosis can have damage to their blood vessels, resulting in increased levels of endothelin in their bloodstream that then causes decreased blood flow to the digits. This can result in very painful digital ulcers. We hope to learn whether blocking the action of endothelin with ambrisentan will be helpful in the treatment and prevention of digital ulcers in patients with systemic sclerosis. This therapy is not approved for the treatment of systemic sclerosis, but this study will help us learn whether ambrisentan is safe and effective in the treatment and prevention of digital ulcers in patients with systemic sclerosis.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: June 2008
Last updated: March 11, 2011

Page last updated: August 23, 2015

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