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View Clinical Trial (Medical Research Study)
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Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine - NCT00775463-29425 (Clinical Trial 248321)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy248321.aspx
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| City: |
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Charleston |
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State:
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SC |
| Zip Code: |
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29425 |
| Conditions: |
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Systemic Sclerosis - Scleroderma |
| Purpose: |
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This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained
release tablets(compared to placebo) on digital ulcers in patients with scleroderma.
Treprostinil diethanolamine is an analog of prostacyclin. Prostacyclin is a naturally
occuring substance produced by the cells of blood vessels that inhibits platelet
aggregation, induces vasodilation, and suppresses smooth muscle proliferation. Improvement
in blood flow in lower limbs and fingers would be anticipated to result in a reduction in
ischemic pain, Raynaud's phenomenon and promote healing of digital ulcers and other ischemic
wounds.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subject gives voluntary written informed consent to participate in the study.
- Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology
(ACR) criteria.
- Males and females age greater than 18 years
- Presence of at least one active digital ulcer (meets protocol defined qualifications
for active digital ulcer)
- Females of childbearing potential must be willing to use a reliable form of
medically acceptable contraception and have a negative pregnancy test
- Able to communicate effectively with study personnel and willing to comply with
protocol requirements.
Exclusion Criteria:
- Diagnosis of pulmonary arterial hypertension (PAH).
- Body weight less than 40 kg
- History of postural hypotension, unexplained syncope, a blood pressure that is less
than 90 mmHg systolic or 50 mmHg diastolic at Screening and Baseline.
- Hemoglobin concentration less than 75% of the lower limit of the normal range
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
- Intractable diarrhea, or severe malabsorption, defined as greater than 15%
unintentional loss of body weight in the last 6 months prior to Screening; any severe
organ failure (e.g., lung, kidney), bleeding diathesis or platelet disorder, or any
life-threatening condition.
- Pregnancy or breast-feeding.
- Overlap with another connective tissue disease that could affect rest pain and hand
function (e.g. diabetes mellitus, rheumatoid arthritis).
- Sympathectomy of the upper limb performed within 12 months of Baseline. Sympathectomy
performed on the non-target limb (hands not presenting with qualifying ulcers) or
which did not include the hand performed within 6 months of Baseline.
- Receipt of prostanoid treatment (epoprostenol, treprostinil sodium, or other
prostacyclin analog) within the previous 3 months of Baseline for conditions
including Reynaud's phenomenon, rest pain and / or digital ulcers.
- Required systemic antibiotics for infected digital ulcers within 2 weeks of
Screening.
- Local injection of botulinum toxin in an affected finger within 1 month prior to
Baseline.
- Treatment with endothelin receptor antagonists within 1 month prior to Baseline.
- Patients on phosphodiasterase inhibitors, such as sildenafil, or tadalafil, who have
received treatment for less than 6 months prior to Baseline (unless for intermittent
treatment of male erectile dysfunction).
- Treatment with statin within 1 month prior to Screening, unless for management of
hyperlipidemia.
- Received an investigational product within 1 month preceding Screening.
- Known hypersensitivity to treprostinil diethanolamine or any of the excipients.
- Tobacco use at any level within the past 6 months prior to Screening. |
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| Study is available at: |
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Medical University of South Carolina
Charleston, SC 29425
United States
Primary Contact:
Kelley Gibson
Email: gibsonke@musc.edu
Phone: 843-792-5290
Secondary Contact:
Kristan Rollins, PharmD
Email: krollins@unither.com
Phone: 919-425-8167 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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