Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
A Study to Evaluate Pregabalin in Painful Diabetic Peripheral Neuropathy
Sponsor:
CSPC Ouyi Pharmaceutical Co Ltd
Organization:
CSPC Ouyi Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Pregabalin Sustained-Release Tablets for the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy postherpetic neuralgia and neuralgia associated with spinal cord injury Pregabalin extended-release tablets were administered once daily as a single dose after dinner Compared with pregabalin capsule formulation it reduces the frequency of medication and improves patient compliance
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled trial the study was designed to evaluate the efficacy and safety of pregabalin sustained-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy The study includes a screening period 3 weeks including baselinerun-in period a treatment period titration period fixed dose period and withdrawal period and a follow-up period During the treatment period participants will receive pregabalin sustained-release tabletsplacebo as daily treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None