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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480753
• Other study ID #: 07-003
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2007
• Last updated: December 18, 2007
• Start date: May 2007
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease
• Raynaud's Disease

Intervention

Drug:
• Nitroglycerin

Locations

Country	Name	City	State
United States	The Center for Rheumatology	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		130 minutes
Secondary	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.		130 minutes
Secondary	Frequency and severity of adverse events		2 weeks