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A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00577304
Recruitment Status : Unknown
Verified April 2008 by MediQuest Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : December 20, 2007
Last Update Posted : February 5, 2010
Sponsor:
Information provided by:
MediQuest Therapeutics

Tracking Information
First Submitted Date  ICMJE December 18, 2007
First Posted Date  ICMJE December 20, 2007
Last Update Posted Date February 5, 2010
Study Start Date  ICMJE December 2007
Estimated Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Reduction in Raynaud's Condition Score [ Time Frame: three months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
Frequency and severity of adverse events. [ Time Frame: three months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon
Official Title  ICMJE A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Raynaud's Disease
  • Raynaud's Disease Secondary to Scleroderma
  • Raynaud's Disease Secondary to Other Autoimmune Disease
Intervention  ICMJE
  • Drug: Nitroglycerin
    Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix with Nitroglycerin. Each dose contains 4.5mg of Nitroglycerin. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
  • Drug: Topical AmphiMatrix
    Individual pouch applicators containing 0.5 grams of Topical AmphiMatrix. Each dose is intended for topical usage on both hands up to five minutes before an anticipated Raynaud's attack or up to 5 minutes after the beginning of an actual Raynaud's attack. Limited to four applications per day; minimum of two hours between applications.
Study Arms  ICMJE
  • 2
    Placebo - Topical AmphiMatrix
    Intervention: Drug: Topical AmphiMatrix
  • Active Comparator: 1
    Topical AmphiMatrix with Nitroglycerin
    Intervention: Drug: Nitroglycerin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 18, 2007)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2008
Estimated Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00577304
Other Study ID Numbers  ICMJE 07-005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Dechow/President and CEO, MediQuest Therapeutics, Inc.
Study Sponsor  ICMJE MediQuest Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jan Ohrstrom, PhD MediQuest Therapeutics
PRS Account MediQuest Therapeutics
Verification Date April 2008

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