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Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by MediQuest Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00934427
First received: June 26, 2009
Last updated: July 19, 2010
Last verified: July 2010

June 26, 2009
July 19, 2010
June 2009
June 2010   (final data collection date for primary outcome measure)
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00934427 on ClinicalTrials.gov Archive Site
  • Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in duration of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in number of Raynaud's attacks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the Raynaud's Condition Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes in the maximum reduction in skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in overall disease severity measures [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Changes in the time to return to baseline skin temperature [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms
A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Raynaud Disease
  • Drug: 0.9% nitroglycerin in TAM cream
    0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
    Other Name: Vascana
  • Drug: vehicle cream
    0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures
  • Active Comparator: Vascana
    Intervention: Drug: 0.9% nitroglycerin in TAM cream
  • Placebo Comparator: Vehicle
    Intervention: Drug: vehicle cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
July 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
  • a history of at least two Raynaud's events during a typical winter day
  • must be willing to apply creams to fingers
  • must be willing to undergo cold temperature exposure
  • must be willing and able to stop certain medications
  • must be willing to use effective contraception, if applicable

Exclusion Criteria:

  • had a Raynaud's attack that required hospital or clinic intervention
  • has allergies to nitroglycerin or topical medication ingredients
  • has a history of migraine or chronic pain
  • has an unstable medical problem that could interfere with the study
  • had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
  • used any investigational drug in the past 4 weeks
  • has significantly abnormal laboratory tests
  • had certain major surgeries in the past 6 months
  • has skin lesions on certain parts of the fingers
  • women who are pregnant or nursing
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00934427
09-001
No
Jeff Gregory, MD / Medical Director, MediQuest Therapeutics
MediQuest Therapeutics
Not Provided
Study Director: Jeff Gregory, MD MediQuest Therapeutics
MediQuest Therapeutics
July 2010

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