Raynaud's Disease Clinical Trial
Official title:
Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
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.
It is the intention of this protocol to study, in a controlled manner, the response of
fingers of patients with Raynaud's phenomenon to two dosage strengths of a fast acting
topical formulation of Nitroglycerin, MQX-503. Patients may have moderate to severe primary
Raynaud's phenomenon or Raynaud's phenomenon secondary to autoimmune diseases such as
scleroderma.
Quantitative changes in blood flow in the fingers of the non-dominant hand will be measured
after the clinical induction of constriction of blood vessels by exposure to local cold
temperatures. Secondarily, the quantitative reduction in skin temperature recovery time and
symptoms of pain, tingling and numbness associated with Raynaud's phenomenon will be
evaluated using a patient hand symptom analog assessment score. The frequency and severity
of adverse events associated with MQX-503 will be assessed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00000530 -
Raynaud's Treatment Study (RTS)
|
Phase 3 | |
| Completed |
NCT00048776 -
Safety and Efficacy of Pletal (Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
|
Phase 4 | |
| Completed |
NCT00048763 -
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
|
Phase 4 | |
| Enrolling by invitation |
NCT02615964 -
Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet.
|
N/A | |
| Completed |
NCT01309802 -
A Two-Part Study of BOTOX® Therapy for Ischemic Digits
|
Phase 2 | |
| Completed |
NCT02396238 -
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells (STAR)
|
N/A | |
| Completed |
NCT00351117 -
St. John's Wort in the Treatment of Raynaud's Phenomenon
|
Phase 3 | |
| Completed |
NCT00528242 -
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease
|
Phase 2 | |
| Completed |
NCT00378521 -
Dose Response Study of a Topical Gel for the Treatment of Raynaud's Phenomenon
|
Phase 2 | |
| Completed |
NCT02683408 -
Diosmiplex (Vasculera®) in Primary and Secondary Raynaud's Phenomenon
|
N/A | |
| Active, not recruiting |
NCT00577304 -
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
|
Phase 3 | |
| Completed |
NCT00419419 -
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon
|
Phase 3 | |
| Completed |
NCT00266669 -
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon
|
Phase 3 | |
| Completed |
NCT01090492 -
PF-00489791 For The Treatment Of Raynaud's
|
Phase 2 |