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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Osteoporosis Medical Center, Beverly Hills, CA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, lyrica, pregabalin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • David Silver MD Inc
  • Stuart L Silverman MD Inc.
  • Talbert Medical Group
  • Catalina Pointe Clinial Research
  • Affilaites in Medical Specialty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flexible Dose

Fixed Dosing

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Global Impression of Change
Discontinuation rate
Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.
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

Full Information

First Posted
October 1, 2010
Last Updated
July 30, 2012
Sponsor
Osteoporosis Medical Center, Beverly Hills, CA
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01226667
Brief Title
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Acronym
Flexdose
Official Title
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Osteoporosis Medical Center, Beverly Hills, CA
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, lyrica, pregabalin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flexible Dose
Arm Type
Active Comparator
Arm Description
flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks
Arm Title
Fixed Dosing
Arm Type
Active Comparator
Arm Description
75 mg BID for one week and increased to 150 mg BID for 7 weeks
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score evaluation by NRS
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change
Time Frame
At weeks 4 and 8
Title
Discontinuation rate
Description
Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.
Time Frame
9 weeks
Title
Improvements in Wolfe Symptom Severity Score
Description
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
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keaton Nasser
Organizational Affiliation
Osteoporosis Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stuart L Silverman, M.D.
Organizational Affiliation
Osteoporosis Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Silver MD Inc
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Stuart L Silverman MD Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Catalina Pointe Clinial Research
City
Tucson
State/Province
California
ZIP/Postal Code
85704
Country
United States
Facility Name
Affilaites in Medical Specialty
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23983064
Citation
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.
Results Reference
derived

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Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

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