Clinical trial NCT00480753: Dose Response Study of a Topical Formulation of Nitroglycerin for the Treatment of Raynaud's Phenomenon
Official title: Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Raynaud's Disease
Keywords: Raynaud's phenomenon
Raynaud's Disease
Raynaud's disease secondary to scleroderma
Raynaud's phenomenon secondary to autoimmune disease
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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.
timeFrame: 130 minutes
Secondary outcomes:
measure: 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.
timeFrame: 130 minutes
measure: Frequency and severity of adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Albany
country: United States
facility: The Center for Rheumatology
state: New York
Study officials:
affiliation: The Center for Rheumatology
name: Lee Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References: