Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492323
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2007-06-25
Brief Title:
An Effectiveness and Safety Study With RWJ-333369 Carisbamate for the Study of Postherpetic Neuralgia PHN
Sponsor:
SK Life Science Inc
Organization:
SK Life Science Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group With a Crossover Confirmation Period Study of RWJ-333369 for the Treatment of Postherpetic Neuralgia
Status:
COMPLETED
Status Verified Date:
2018-04
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 study is to evaluate the safety effectiveness and tolerability of 200 mg of RWJ-333369 given twice daily compared with placebo in the treatment of postherpetic neuralgia
Detailed Description:
Postherpetic neuralgia is a distressing syndrome of neuropathic pain that continues for at least 3 months after the resolution of the varicella-zoster rash shingles can last up to years later and for which therapies are often limited by incomplete pain relief and side effects This is a randomized study medication is assigned by chance double-blind neither the Investigator or the patient know the name of the assigned study medication placebo-controlled crossover parallel-group multicenter study to determine the effectiveness and safety of 200 mg of RWJ-333369 given twice daily for 4 weeks compared with placebo in patients with Postherpetic Neuralgia PHN The study hypothesis is that 200 mg of RWJ-333369 given twice daily for 4 weeks will be more effective than placebo in reducing pain due to PHN as measured by average daily PHN pain scores Patients will receive 200 mg of RWJ-333369 or matching placebo tablets given in equally divided doses twice daily by mouth with or without food for 4 weeks in each of the 2 treatment periods
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 333369NPP2001 | None | None | None |