Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004647
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
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:
OBJECTIVES
I Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy
I Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by participating institution
The first group receives oral mexiletine 3 times a day for 6 weeks The dose is increased after the first week if there are no side effects
The second group receives a placebo Patients cross to the alternate treatment after a 1-week washout
The first group receives oral mexiletine 3 times a day for 6 weeks The dose is increased after the first week if there are no side effects
The second group receives a placebo Patients cross to the alternate treatment after a 1-week washout
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTENN-4686 | None | None | None |