Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375960
Status:
COMPLETED
Last Update Posted:
2007-04-02
First Post:
2006-09-11
Brief Title:
A Research Study of V3381 for the Treatment of Diabetic Peripheral Neuropathic Pain
Sponsor:
Vernalis RD Ltd
Organization:
Vernalis RD Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Crossover Study of the Safety Efficacy and Pharmacokinetics of Two Escalating Oral Doses of V3381 200 mg BID and 400 mg BID for 28 Days in Patients With Diabetic Peripheral Neuropathic Pain DPNP
Status:
COMPLETED
Status Verified Date:
2007-03
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 objective of this study is to investigate the safety and efficacy of an investigational drug V3381 for the treatment of diabetic peripheral neuropathic DPN pain pain in ones feet and legs or even in ones hands and arms sometimes experienced by people with diabetes An investigational drug is one that is not approved by the United States Food and Drug Administration FDA andor Health Canada
Detailed Description:
Diabetic Peripheral Neuropathic Pain DPNP is pain in your feet and legs or even in your hands and arms sometimes experienced by people with diabetes Neuropathic pain syndromes are much more common than is perhaps generally recognized Approximately 1 of the population in western countries suffers from neuropathic pain Some clinical conditions are associated with a relatively high incidence of neuropathic pain Approximately 15 of patients with diabetic neuropathy have persistent neuropathic pain in the feet legs and hands
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