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

This study has been completed.

Sponsor:

Information provided by:

MediQuest Therapeutics

ClinicalTrials.gov Identifier:

NCT00841594

First received: February 9, 2009

Last updated: May 13, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2009
Last Updated Date	May 13, 2011
Start Date ^ICMJE	February 2009
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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 Arm (s)	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	12
Completion Date	March 2009
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.
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00841594
Other Study ID Numbers ^ICMJE	08-001
Has Data Monitoring Committee	No
Responsible Party	Fredrick Dechow, President and CEO, MediQuest Therapeutics, Inc.
Study Sponsor ^ICMJE	MediQuest Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MediQuest Therapeutics
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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