Trial | NCT01226667  Report issue

Official Title

Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pregabalin ...

  • Study Participants

    174
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.
Study Started
Jul 31
2010
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Jul 31
2012
Estimate

Drug Pregabalin

Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid. Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.

Flexible Dose Active Comparator

flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks

Fixed Dosing Active Comparator

75 mg BID for one week and increased to 150 mg BID for 7 weeks

Criteria 

Inclusion Criteria:

diagnosis of fibromyalgia by ACR criteria
ambulatory patients
complete of 5 pain diaries during 1 week evaluation
other inclusion criteria may apply

Exclusion Criteria:

pregnant or of childbearing potential not using contraceptives
use of pregabalin in the past
concomitant use of opioids or gabapentin
estimated creatinine clearance less than 60
other criteria may apply
No Results Posted