Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419419
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2007-01-04
Brief Title:
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynauds Phenomenon
Sponsor:
MediQuest Therapeutics
Organization:
MediQuest Therapeutics
Study Overview
Official Title:
Phase III In-Life Study of a Topical Gel Formulation of Nitroglycerin MQX-503 and Matching Placebo Gel in the Treatment and Prevention 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:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety tolerability and effectiveness of Topical AmphiMatrix with Nitroglycerin MQX-503 to relieve Raynauds symptoms and increase blood flow to the fingers
Detailed Description:
The purpose of this clinical study is to determine in a controlled fashion the ability of Topical AmphiMatrix formulation with Nitroglycerin MQX-503 to improve the patients health assessment as indicated by patient and physician assessments decrease the frequency of Raynauds events decrease the duration of Raynauds events and decrease the symptoms pain tingling numbness in the fingers of Raynauds patients The study will include patients with moderate to severe primary Raynauds phenomenon and with Raynauds phenomenon secondary to autoimmune diseases such as scleroderma
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