Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

— Flexdose  

Official title:

Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226667
• Other study ID #: SLS2009001
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2010
• Last updated: July 30, 2012
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Osteoporosis Medical Center, Beverly Hills, CA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	David Silver MD Inc	Beverly Hills	California
United States	Stuart L Silverman MD Inc.	Beverly Hills	California
United States	Talbert Medical Group	Huntington Beach	California
United States	Catalina Pointe Clinial Research	Tucson	California
United States	Affilaites in Medical Specialty	West Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Osteoporosis Medical Center, Beverly Hills, CA	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score evaluation by NRS	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.	8 weeks	No
Secondary	Patient Global Impression of Change		At weeks 4 and 8	No
Secondary	Discontinuation rate	Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.	9 weeks	Yes
Secondary	Improvements in Wolfe Symptom Severity Score	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	9 weeks	No