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Scleroderma, Systemic clinical trials

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NCT ID: NCT00848939 Completed - Systemic Sclerosis Clinical Trials

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

DISTOL-PK
Start date: December 2008
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.

NCT ID: NCT00843102 Completed - Systemic Sclerosis Clinical Trials

Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

Start date: December 2007
Phase: N/A
Study type: Observational

Aim: Determination of frequency and nature of coronary involvement (including epicardial and microvascular) among scleroderma patients referred for right heart catheterization.

NCT ID: NCT00775463 Completed - Systemic Sclerosis Clinical Trials

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

DISTOL-1
Start date: May 2009
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT00764309 Completed - Scleroderma Clinical Trials

Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

Start date: January 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.

NCT ID: NCT00740285 Completed - Scleroderma Clinical Trials

Effectiveness and Safety of Lidocaine for Scleroderma

Start date: April 2004
Phase: Phase 2/Phase 3
Study type: Interventional

Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.

NCT ID: NCT00725361 Completed - Clinical trials for Scleroderma, Systemic

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

Start date: June 2008
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00707187 Completed - Systemic Sclerosis Clinical Trials

Trial of IC351 in Female Scleroderma Patients With Raynaud's and Sexual Dysfunction

Start date: July 2001
Phase: Phase 2
Study type: Interventional

Purpose of the study is to evaluate the effectiveness and safety of a new investigational dur, IC351. Study is designed to gather information regarding the possible usefulness of IC351 as a treatment of several blood vessel features of scleroderma. This includes Raynaud phenomenon as well as the vaginal dryness and discomfort associated with scleroderma

NCT ID: NCT00704665 Completed - Systemic Sclerosis Clinical Trials

Recombinant Human Relaxin in the Treatment of Diffuse Scleroderma

Start date: December 1998
Phase: Phase 3
Study type: Interventional

Relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. It has ani-fibrotic properties. Previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. Study is designed to see if skin improvement and improvement in functional ability can be achieved.

NCT ID: NCT00697736 Completed - Clinical trials for Systemic Scleroderma

Cardiac Repercussion of Systemic Sclerodermias

HTAP-SCLERO
Start date: March 2007
Phase: N/A
Study type: Interventional

Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT). In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques. So, the analysis of the right ventricular function appears capital, because: - it is recognized like an essential determinant of the symptoms and effort capacity, - its prevalence, physiopathology and prognostic values remain unknown in this pathology, - its interest in the starting of the treatment remains to be specified. The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT: - the incidence of a right ventricular dysfonction, evaluated by the analysis of the myocardic regional function with myocardial tissular Doppler mode, - the physiopathology of this damage by correlation with the tests of respiratory function and the not invasive hemodynamic datas at rest and exercise. - the prognosis value of the abnormalities of the right ventricular function by a follow-up of these patients over a 5 years period. This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.

NCT ID: NCT00668473 Completed - Systemic Sclerosis Clinical Trials

Angiogenic/Angiostatic Mediators in Patients With Systemic Sclerosis

Start date: May 2007
Phase: N/A
Study type: Observational

We propose to examine several angiogenic/angiostatic mediators in the skin and serum of subjects with SSc and compare it to levels found in the skin and serum of healthy subjects.