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Trial record 9 of 460 for:    applied AND ointment

MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison

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: NCT00841594
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
MediQuest Therapeutics

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 11, 2009
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Measurement and comparison of the levels of nitroglycerin and its dinitrate metabolites in the blood of healthy human volunteers after a single topical dose of MQX 503 and a single topical dose of Nitroglycerin Ointment 2%, USP. [ Time Frame: 12 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00841594 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Observation for any adverse events such as headache. [ Time Frame: 3 weeks ]
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 MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison
Official Title  ICMJE MXQ-503 Applied To The Hand Vs. Nitroglycerin Ointment 2%, USP, Applied To The Chest: A Pharmacokinetic Comparison In Normal Subjects
Brief Summary The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Raynaud's Phenomenon
Intervention  ICMJE
  • Drug: nitroglycerin 0.9 % (MXQ-503)
    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
  • Drug: Nitroglycerin ointment 2%, USP
    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.
Study Arms  ICMJE
  • Active Comparator: 1

    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

    Applied to the hand.

    Intervention: Drug: nitroglycerin 0.9 % (MXQ-503)
  • Active Comparator: 2

    MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

    Applied to the chest.

    Intervention: Drug: Nitroglycerin ointment 2%, USP
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 Completed
Estimated Enrollment  ICMJE
 (submitted: February 10, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 50 years of age
  • Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
  • Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.

Exclusion Criteria:

  • Subjects who can not safely discontinue current prescription medications.
  • Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
  • Subjects with an unstable medical problem.
  • Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
  • Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
  • Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
  • Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
  • Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
  • Pregnant or nursing women.
  • Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00841594
Other Study ID Numbers  ICMJE 08-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fredrick Dechow, President and CEO, MediQuest Therapeutics, Inc.
Study Sponsor  ICMJE MediQuest Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MediQuest Therapeutics
Verification Date May 2011

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