Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253331
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2005-11-13
Brief Title:
Lab Study of MQX-503 in Treatment of Raynauds
Sponsor:
MediQuest Therapeutics
Organization:
MediQuest Therapeutics
Study Overview
Official Title:
Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin MQX-503 in the Treatment of Raynauds Phenomenon
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Raynauds 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 hisher own control in interpreting the response
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 hisher own control in interpreting the response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None