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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90211
        • David Silver MD Inc
      • Beverly Hills, California, United States, 90211
        • Stuart L Silverman MD Inc.
      • Huntington Beach, California, United States, 92646
        • Talbert Medical Group
      • Tucson, California, United States, 85704
        • Catalina Pointe Clinial Research
      • West Hills, California, United States, 91307
        • Affilaites in Medical Specialty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score evaluation by NRS
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Change
Time Frame: At weeks 4 and 8
At weeks 4 and 8
Discontinuation rate
Time Frame: 9 weeks
Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.
9 weeks
Improvements in Wolfe Symptom Severity Score
Time Frame: 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
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Keaton Nasser, Osteoporosis Medical Center
  • Principal Investigator: Stuart L Silverman, M.D., Osteoporosis Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Pregabalin

3
Subscribe