Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135109
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2005-08-23
Brief Title:
Trial to Assess the Efficacy and Safety of SPM 927 200 400 and 600mgDay in Subjects With Painful Distal Diabetic Neuropathy
Sponsor:
UCB Pharma
Organization:
UCB Pharma
Study Overview
Official Title:
A Multi-Center Randomized Double-Blind Placebo-Controlled Parallel-Group Trial to Assess the Efficacy and Safety of SPM 927 200 400 and 600mgDay in Subjects With Painful Distal Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2010-02
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:
This phase 3 trial is being conducted at approximately 80 sites in the United States US to investigate whether lacosamide SPM 927 at different doses reduces pain in subjects with diabetic neuropathy Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide To qualify for this trial subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale 0-10 scale during the 7 day period prior to the start of treatment
To determine what effect lacosamide has on diabetic neuropathic pain subjects will use a diary to record their daily pain intensity morning and evening and pain interference with sleep morning and activity evening Use of rescue medication acetaminophen and subjects quality of life will be investigated In addition the safety and tolerability of the different doses of lacosamide will be investigated
To determine what effect lacosamide has on diabetic neuropathic pain subjects will use a diary to record their daily pain intensity morning and evening and pain interference with sleep morning and activity evening Use of rescue medication acetaminophen and subjects quality of life will be investigated In addition the safety and tolerability of the different doses of lacosamide will be investigated
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