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

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00480753
First received: May 29, 2007
Last updated: December 18, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Raynaud's Disease
Drug: Nitroglycerin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon

Resource links provided by NLM:


Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:
  • 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. [ Time Frame: 130 minutes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 130 minutes ]
  • Frequency and severity of adverse events [ Time Frame: 2 weeks ]

Estimated Enrollment: 15
Study Start Date: May 2007
Study Completion Date: August 2007
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480753

Locations
United States, New York
The Center for Rheumatology
Albany, New York, United States, 12206
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
Principal Investigator: Lee Shapiro, MD The Center for Rheumatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480753     History of Changes
Other Study ID Numbers: 07-003
Study First Received: May 29, 2007
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:
Raynaud's phenomenon
Raynaud's Disease
Raynaud's disease secondary to scleroderma
Raynaud's phenomenon secondary to autoimmune disease

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014