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Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia (Flexdose)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Osteoporosis Medical Center, Beverly Hills, CA
ClinicalTrials.gov Identifier:
NCT01226667
First received: October 1, 2010
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 Drug: Pregabalin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Osteoporosis Medical Center, Beverly Hills, CA:

Primary Outcome Measures:
  • Pain score evaluation by NRS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Patient Global Impression of Change [ Time Frame: At weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Discontinuation rate [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.

  • Improvements in Wolfe Symptom Severity Score [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 174
Study Start Date: July 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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.
Active Comparator: Fixed Dosing
75 mg BID for one week and increased to 150 mg BID for 7 weeks
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226667

Locations
United States, California
Stuart L Silverman MD Inc.
Beverly Hills, California, United States, 90211
David Silver MD Inc
Beverly Hills, California, United States, 90211
Talbert Medical Group
Huntington Beach, California, United States, 92646
Catalina Pointe Clinial Research
Tucson, California, United States, 85704
Affilaites in Medical Specialty
West Hills, California, United States, 91307
Sponsors and Collaborators
Osteoporosis Medical Center, Beverly Hills, CA
Pfizer
Investigators
Study Director: Keaton Nasser Osteoporosis Medical Center
Principal Investigator: Stuart L Silverman, M.D. Osteoporosis Medical Center
  More Information

No publications provided

Responsible Party: Osteoporosis Medical Center, Beverly Hills, CA
ClinicalTrials.gov Identifier: NCT01226667     History of Changes
Other Study ID Numbers: SLS2009001
Study First Received: October 1, 2010
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Osteoporosis Medical Center, Beverly Hills, CA:
fibromyalgia
lyrica
pregabalin

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013