Lab Study of MQX-503 in Treatment of Raynaud's
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ClinicalTrials.gov Identifier: NCT00253331 |
Recruitment Status
:
Completed
First Posted
: November 15, 2005
Last Update Posted
: May 30, 2007
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Tracking Information | |||||||
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First Submitted Date ICMJE | November 13, 2005 | ||||||
First Posted Date ICMJE | November 15, 2005 | ||||||
Last Update Posted Date | May 30, 2007 | ||||||
Study Start Date ICMJE | November 2004 | ||||||
Primary Completion Date | Not Provided | ||||||
Current Primary Outcome Measures ICMJE |
Differntial time for blood flow to return to baseline following cold exposure. | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00253331 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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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 | Lab Study of MQX-503 in Treatment of Raynaud's | ||||||
Official Title ICMJE | Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud’s Phenomenon | ||||||
Brief Summary | The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures. Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours. Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response. |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: topical organogel with nitroglycerin | ||||||
Study Arms | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Enrollment ICMJE |
36 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date | September 2005 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | 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 | NCT00253331 | ||||||
Other Study ID Numbers ICMJE | MQT 03-001 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | MediQuest Therapeutics | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | MediQuest Therapeutics | ||||||
Verification Date | May 2007 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |