Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

NCT01226667

Last updated date
Study Location
David Silver MD Inc
Beverly Hills, California, 90211, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- diagnosis of fibromyalgia by ACR criteria

- ambulatory patients

- complete of 5 pain diaries during 1 week evaluation

- other inclusion criteria may apply

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Official Title  ICMJE Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Active Comparator: Flexible Dose
    flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks
    Intervention: Drug: Pregabalin
  • Active Comparator: Fixed Dosing
    75 mg BID for one week and increased to 150 mg BID for 7 weeks
    Intervention: Drug: Pregabalin
Publications * Nasser K, Kivitz AJ, Maricic MJ, Silver DS, Silverman SL. Twice daily versus once nightly dosing of pregabalin for fibromyalgia: a double-blind randomized clinical trial of efficacy and safety. Arthritis Care Res (Hoboken). 2014 Feb;66(2):293-300. doi: 10.1002/acr.22111.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2012)
174
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2010)
172
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01226667
Other Study ID Numbers  ICMJE SLS2009001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Osteoporosis Medical Center, Beverly Hills, CA
Study Sponsor  ICMJE Osteoporosis Medical Center, Beverly Hills, CA
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Keaton NasserOsteoporosis Medical Center
Principal Investigator:Stuart L Silverman, M.D.Osteoporosis Medical Center
PRS Account Osteoporosis Medical Center, Beverly Hills, CA
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP