Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
Information source: MediQuest Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Raynaud's Disease
Intervention: Nitroglycerin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: MediQuest Therapeutics Official(s) and/or principal investigator(s):
Lee Shapiro, MD, Principal Investigator, Affiliation: The Center for Rheumatology
Summary
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.
Clinical Details
Official title: Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Changes in blood flow in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.
Secondary outcome: Reduction in skin temperature recovery time and symptoms in the fingers of the non-dominant hand after the induction of constriction of blood vessels by exposure to local cold temperatures.Frequency and severity of adverse events
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with Raynaud's phenomenon
- Patients who are willing to discontinue any current therapies for Raynaud's
phenomenon
Exclusion Criteria:
- The use of any medication containing nitroglycerin or known to interact with
nitroglycerin
- Patients with a history of migraine or other severe headaches
- Open skin lesions or skin conditions in the area where medication is to be applied
- Pregnant or nursing women or those wishing to become pregnant.
Locations and Contacts
The Center for Rheumatology, Albany, New York 12206, United States
Additional Information
Starting date: May 2007
Last updated: December 18, 2007
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