Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Phase 4

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Pregabalin

• Registration Number: NCT01226667
• Lead Sponsor: Osteoporosis Medical Center, Beverly Hills, CA

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

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-22
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Dosing	Pregabalin	75 mg BID for one week and increased to 150 mg BID for 7 weeks
Flexible Dose	Pregabalin	flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks

Primary Outcome Measures

Name	Time	Method
Pain score evaluation by NRS	8 weeks	Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	At weeks 4 and 8
Discontinuation rate	9 weeks	Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.
Improvements in Wolfe Symptom Severity Score	9 weeks	Wolfe Symptom Severity scales for pain, fatigue, trouble sleeping, trouble with anxiety or depression, trouble thinking or remembering, overall FM severity, problems awaking feeling unrefreshed

Trial Locations

Locations (5)

Stuart L Silverman MD Inc.; 🇺🇸 Beverly Hills, California, United States

Affilaites in Medical Specialty; 🇺🇸 West Hills, California, United States

David Silver MD Inc; 🇺🇸 Beverly Hills, California, United States

Talbert Medical Group; 🇺🇸 Huntington Beach, California, United States

Catalina Pointe Clinial Research; 🇺🇸 Tucson, California, United States