Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00307749
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2006-03-27
Brief Title:
Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
A Phase II Randomized Double-Blind Placebo-Controlled 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy
Status:
COMPLETED
Status Verified Date:
2007-12
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 primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
Detailed Description:
The study will use a double-blind randomized placebo-controlled fixed-dose parallel-group design Patients will be randomized equally to 1 of 4 treatment groups MCC-257 20 mg MCC-257 40 mg MCC-257 80 mg or placebo given once daily for 24 weeks The study will consist of 2 periods 1 a screening period of up to 21 days prior to baseline including a formal screening visit and 2 a 24-week treatment period during which patients will take the study treatment and have various assessments performed during 4 visits
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