Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335933
Status:
COMPLETED
Last Update Posted:
2007-08-02
First Post:
2006-06-08
Brief Title:
Safety and Efficacy of Gabapentin in Postherpetic Neuralgia
Sponsor:
Depomed
Organization:
Depomed
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release G-ER Tablets in the Treatment of Patients With Postherpetic Neuralgia
Status:
COMPLETED
Status Verified Date:
2006-06
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:
Gabapentin and pregabalin are treatments for some types of neuropathic pain including postherpetic neuralgia PHN However these treatments usually need to be taken 3 times a day for effective pain control The purpose of this study is to determine whether a new gabapentin tablet which only needs to be taken once or twice a day is safe and effective for the treatment of postherpetic neuralgia
Detailed Description:
The primary study objective is to assess the relative efficacy of G-ER dosed once daily 1800 mg following the evening meal or twice daily 600 mg AM1200 mg PM versus placebo in reducing the mean daily pain score from the baseline week to the end of the efficacy treatment period Treatment Week 10 in patients with PHN
Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores Short-Form McGill Pain Questionnaire SF-MPQ the Neuropathic Pain Scale NPS Brief Pain Inventory BPI Patient Global Impression of Change PGIC and Investigator-Rated Clinical Global Impression of Change CGIC
Secondary efficacy measures will include changes from baseline in mean weekly sleep interference scores Short-Form McGill Pain Questionnaire SF-MPQ the Neuropathic Pain Scale NPS Brief Pain Inventory BPI Patient Global Impression of Change PGIC and Investigator-Rated Clinical Global Impression of Change CGIC
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