n UlcerNCT00725361
A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
A study testing Ambrisentan in people with n Ulcer and Scleroderma, Systemic, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- n Ulcer, Scleroderma, Systemic
- What is being tested?
- Ambrisentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.
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.
Read the 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.
- Conditions
- n Ulcer, Scleroderma, Systemic
- Being tested
- Ambrisentan
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmbrisentanDrug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Ambrisentan Receives: Drug: Ambrisentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks prior to week 24
Secondary outcomes (4)
New DU 4 Weeks Prior to Week 12
The number of new DU that have developed in the preceding 4 weeks assessed at week 12 from baseline.
Measured: 4 weeks prior to week 12
Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.
Measured: 12 weeks
Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.
Measured: 12 weeks
Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.
Range is 0-3 with 0 meaning the least amount of disability and 3 the greatest of disability.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for n UlcerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorinda S Chung, Stanford University
- Investigators
- Lorinda S Chung, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725361
- Sponsor's protocol ID
- SU-07222008-1265
- Other IDs
- IRB Protocol # 14409
- Status last verified
- Mar 2017
- First submitted
- 28 Jul 2008
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Ambrisentan in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis.
- ClinicalTrials.gov ID
- NCT00725361
- Acronym / sponsor ID
- SU-07222008-1265
- Conditions
- n Ulcer, Scleroderma, Systemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 24 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: AmbrisentanAmbrisentan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambrisentan | Drug | Active |
Primary outcome
New Digital Ulcers (DU) 4 Weeks Prior to Week 24
Time frame: 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 secondary outcomes
New DU 4 Weeks Prior to Week 12
Time frame: 4 weeks prior to week 12
Subjects Experiencing Complete (Total Reepithelialization) Healing of All Baseline DU at Week 12.
Time frame: 12 weeks
Subjects Experiencing Complete Healing of > 50% of the Number of Baseline DU at Week 12.
Time frame: 12 weeks
Change in the Scleroderma Health Assessment Questionnaire (SHAQ) at Week 24 Compared With Baseline.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorinda S Chung principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambrisentan in people with n Ulcer and Scleroderma, Systemic, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Digital Ulcers (DU) 4 Weeks Prior to Week 24 (time frame: 4 weeks prior to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.