Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

April 11, 2014 updated by: Don L. Goldenberg MD, Newton-Wellesley Hospital

Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin

The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The randomized clinical trial of pregabalin in early-onset fibromyalgia.

At the baseline visit, each subject will be asked if they wish to consider enrolling in Part II. If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia.

After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.

Study Type

Interventional

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

  • United States
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix)

    • Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix)
    • Patients have a pain VAS > 4
    • Patients are able to understand and sign informed consent
    • Patients are able to understand and complete study questionnaires
    • Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix).
    • Age - > 18
    • Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period

Exclusion Criteria:

  • • Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis

    • Any subject with suicidal thoughts in the past or currently
    • Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts
    • Women who are breast feeding
    • Men or women who plan to have children during the course of the study
    • Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study
    • Unable to discontinue any mediations used for sleep disturbances
    • Patients currently being treated for any psychiatric illness including depression or anxiety disorder
    • Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications.
    • Inability to understand and sign informed consent and complete questionnaires.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Names:
  • Lyrica
Experimental: Pregabalin
Drug: Pregabalin
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Other Names:
  • Lyrica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in pain VAS from study entry to end of study
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in total score FIQ from study entry to last visit.
Time Frame: 12 weeks
12 weeks
Change in total score FM 2010 Clinical Scale from study entry to last visit.
Time Frame: 12 Weeks
12 Weeks
Change in PGIC from study entry to last visit.
Time Frame: 12 weeks
12 weeks
Change in total score for HRQOL from study entry to last visit.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Newton-Wellesley Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Don Goldenberg, MD, Newton-Wellesley Hospital

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.

General Publications

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

September 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N11-507

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe