A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

May 14, 2013 updated by: Pfizer

An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

246

Phase

  • Phase 2

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
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85007
        • Pfizer Investigational Site
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
    • California
      • Auburn, California, United States, 95602
        • Pfizer Investigational Site
      • Orangevale, California, United States, 95662
        • Pfizer Investigational Site
      • Pismo Beach, California, United States, 93449
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • Pfizer Investigational Site
    • Florida
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
      • Moline, Illinois, United States, 61265
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
    • Kansas
      • Pratt, Kansas, United States, 67124
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Pfizer Investigational Site
      • Mansfield, Massachusetts, United States, 02048
        • Pfizer Investigational Site
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01610
        • Pfizer Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • Kansas City, Missouri, United States, 64106
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10022-1009
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28209-3734
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45402
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Bensalem, Pennsylvania, United States, 19020
        • Pfizer Investigational Site
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Camp Hill, Pennsylvania, United States, 17011
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635-0909
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Georgetown, Texas, United States, 78626
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77024
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78213
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site

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:

  • At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
  • At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ).

Exclusion Criteria:

  • Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
  • Patients with severe hepatic impairment.

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weekly Average Pain Score from the Daily Pain Diary.

Secondary Outcome Measures

Outcome Measure
Patient Global Impression of Change
Safety and Tolerability
Sheehan Disability Scale
Short-Form McGill Pain Questionnaire (SF-MPQ)
Fibromyalgia Impact Questionnaire (FIQ) Total Score
Short-Form 36 Health Survey (SF 36)
Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale)
Quality of Sleep Score from the Daily Sleep Diary
Multidimensional Assessment of Fatigue (MAF)
Hospital Anxiety and Depression Scales (HADS)
Fibromyalgia Health Assessment Questionnaire (F-HAQ)
Exposure Response Relationship Between Daily Dose and Daily Pain Score

Collaborators and Investigators

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

Sponsor

Pfizer

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

Helpful Links

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

August 1, 2006

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

July 26, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (ESTIMATE)

July 28, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061034

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.

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