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A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
This study is ongoing, but not recruiting participants.
Study NCT00577304   Information provided by MediQuest Therapeutics
First Received: December 18, 2007   Last Updated: April 24, 2008   History of Changes

December 18, 2007
April 24, 2008
December 2007
March 2008   (final data collection date for primary outcome measure)
Reduction in Raynaud's Condition Score [ Time Frame: three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577304 on ClinicalTrials.gov Archive Site
Frequency and severity of adverse events. [ Time Frame: three months ] [ Designated as safety issue: Yes ]
Same as current
 
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of Nitroglycerin, MQX-503, to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's Phenomenon (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
  • Raynaud's Disease
  • Raynaud's Disease Secondary to Scleroderma
  • Raynaud's Disease Secondary to Other Autoimmune Disease
  • Drug: Nitroglycerin
  • Drug: Topical AmphiMatrix
  • Other: Placebo - Topical AmphiMatrix
  • Active Comparator: Topical AmphiMatrix with Nitroglycerin
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
March 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Outpatients ages 15 - 70.
  • Patients with a diagnosis of Raynaud's phenomenon.
  • Patients who agree to apply study medication to their fingers.
  • Patients who are willing to stop current topical vasodilator therapies.
  • Patients who agree not to start or change dosage of current oral vasodilator therapies.
  • Patients who agree not to use any nitrate therapy while participating in this study.
  • Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.

Exclusion Criteria:

  • Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
  • Patients who have an allergy to nitroglycerin or common topical gel ingredients.
  • Patients with a history of severe headaches.
  • Patients with an unstable medical problem.
  • Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
  • Patients who have had a recent heart attack or other uncontrolled heart condition.
  • Patients who have participated in an investigational drug study within four weeks of visit one.
  • Patients who have clinically significant abnormal lab values.
  • Patients who have had recent major abdominal, thoracic or vascular surgery.
  • Patients with interfering skin conditions.
  • Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
Both
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577304
Fred Dechow/President and CEO, MediQuest Therapeutics, Inc.
07-005
MediQuest Therapeutics
 
Study Director: Jan Ohrstrom, PhD MediQuest Therapeutics
MediQuest Therapeutics
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP