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Raynaud Disease clinical trials

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NCT ID: NCT01233999 Completed - Raynaud's Syndrome Clinical Trials

Botulinum Toxin in the Treatment of Raynaud's

Start date: October 2010
Phase: N/A
Study type: Interventional

The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP. In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another. This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and anticoagulants. If the patient chooses to participate in the study, he/she will be randomly assigned to receive an injection with Botulinum toxin in either the left or right hand. The other hand will be injected with saline solution. Neither the patient nor the physician or research personnel seen in follow-up will know which hand is injected with Botulinum toxin.

NCT ID: NCT01117298 Completed - Scleroderma Clinical Trials

A Randomized Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Start date: November 2009
Phase: Phase 3
Study type: Interventional

Raynaud's phenomenon (RP) associated with scleroderma is a difficult problem to treat. Many patients develop ischemic digital ulcers due to severe RP that causes considerable morbidity and adversely affects the quality of life. In an earlier study, we have observed marked improvement in RP attacks and rapid healing of digital ulcers following therapy with phosphodiesterase V inhibitor, Tadalafil. In the present multicentric study we aim to study the efficacy of Tadalafil in patients continuing to have RP attacks despite using at least one or more vasodilators.

NCT ID: NCT01090492 Completed - Clinical trials for Peripheral Vascular Disease

PF-00489791 For The Treatment Of Raynaud's

Start date: August 4, 2010
Phase: Phase 2
Study type: Interventional

The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.

NCT ID: NCT00946738 Completed - Systemic Sclerosis Clinical Trials

The Effect of Physical Therapy on Raynaud`s Phenomenon Secondary to Systemic Sclerosis

Start date: October 2004
Phase: N/A
Study type: Interventional

The effect of deep oscillation and biofeedback on Raynaud`s phenomenon secondary to systemic sclerosis (SSc) remains to be determined. A prospective randomized controlled pilot study was performed in SSc patients receiving either deep oscillation, biofeedback thrice a week for four weeks or were randomized to the control group.

NCT ID: NCT00700518 Completed - Clinical trials for Raynaud's Phenomenon

Dose Response to Topical Glyceryl Trinitrate in Patients With Raynaud's Phenomenon

Start date: June 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the blood flow response to topical Glyceryl Trinitrate when applied to the skin of patient's fingers with Raynaud's Phenomenon.

NCT ID: NCT00626665 Completed - Raynaud Disease Clinical Trials

Randomised Control Trial to Assess the Efficacy of Tadalafil in Raynaud's Phenomenon in Scleroderma

Start date: December 2007
Phase: Phase 3
Study type: Interventional

In this double-blinded, placebo-controlled, fixed-dose, study patients will be randomly assigned to take placebo or 20 mg tadalafil thrice weekly for 6 weeks. After 6 weeks a wash out period of 2 week will be observed and then the two groups will be switched over to receive the other drug. We planned a priori to include 20 patients. The concomitant medication for treatment of rheumatic disease remained unchanged during the whole study. Patient will undergo clinical and lab evaluation for organ damage for kidney and lungs. ECHO heart will be done at base line to assess the PAH and LV function and repeated at the end of the study. Blood pressure will be recorded at each visit. A physician unaware of the treatment group will record skin score and appearance of new cutaneous ulcers. The primary outcome variables will be frequency and duration of Raynauds attacks, evolution of trophic digital lesions and change in flow mediated dilatation of the brachial artery. Flow mediated dilatation of the brachial artery will be done at baseline 6 and 12 weeks.

NCT ID: NCT00528242 Completed - Raynaud's Disease Clinical Trials

Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

Start date: June 2007
Phase: Phase 2
Study type: Interventional

To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

NCT ID: NCT00498615 Completed - Scleroderma Clinical Trials

A Rho-kinase Inhibitor (Fasudil) in the Treatment of Raynaud's Phenomenon

Start date: April 2007
Phase: Phase 3
Study type: Interventional

Raynaud's phenomenon is thought to occur when, in response to cold or emotional stress, there is closure of the digital arteries and cutaneous arterioles leading to the clinical finding of sharp demarcated digital pallor and cyanosis of the distal skin of the fingers and/or toes. Patients often continue to experience problems despite current available treatment. The investigators' study will investigate the use of a new vasodilator called Fasudil, a Rho-kinase inhibitor. The investigators' hypothesis is that Fasudil will prevent vasoconstriction of digital and cutaneous arteries during a standard laboratory based cold exposure and will therefore improve digital blood flow and skin temperature recovery time following cold challenge. These data will provide the rationale for a more elaborate clinical trials in real life situations.

NCT ID: NCT00480753 Completed - Raynaud's Disease Clinical Trials

Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon

Start date: May 2007
Phase: Phase 2
Study type: Interventional

The purpose of this clinical study is to determine the response to two different dosage strengths of a topical nitroglycerin gel in patients with Raynaud's Phenomenon. Patient fingers will be monitored for changes in blood flow and skin temperature. Symptoms of pain, tingling and numbness will also be monitored.

NCT ID: NCT00419419 Completed - Autoimmune Diseases Clinical Trials

Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.