Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-30 @ 9:26 PM
Study NCT ID:
NCT01226667
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
2010-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Sponsor:
Osteoporosis Medical Center, Beverly Hills, CA
Organization:
Study Overview
Official Title:
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Flexdose
Brief Summary:
A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: