A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

December 10, 2019 updated by: Pfizer

A 14-week, Randomized, Double-blind, Placebo-controlled, Multi-center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1129

Phase

  • Phase 3

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

  • Canada
      • Quebec, Canada, G1V 3M7
        • Pfizer Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • Pfizer Investigational Site
    • New Brunswick
      • Bathurst, New Brunswick, Canada, E2A 4X7
        • Pfizer Investigational Site
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Pfizer Investigational Site
    • Ontario
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3H 5S4
        • Pfizer Investigational Site
    • Quebec
      • Pointe Claire, Quebec, Canada, H9R 3J1
        • Pfizer Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35802
        • Pfizer Investigational Site
      • Tallassee, Alabama, United States, 36078
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85023
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Elk Grove, California, United States, 95758
        • Pfizer Investigational Site
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Lafayette, California, United States, 94549
        • Pfizer Investigational Site
      • Northridge, California, United States, 91325
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95823
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95816
        • Pfizer Investigational Site
      • San Jose, California, United States, 95124
        • Pfizer Investigational Site
      • Santa Ana, California, United States, 92705
        • Pfizer Investigational Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Pfizer Investigational Site
    • Florida
      • Brooksville, Florida, United States, 34601
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32205
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32257
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32223
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34471
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33709
        • Pfizer Investigational Site
      • Sarasota, Florida, United States, 34233
        • Pfizer Investigational Site
      • Sunrise, Florida, United States, 33351
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • Venice, Florida, United States, 34292
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Pfizer Investigational Site
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
      • Moline, Illinois, United States, 61265
        • Pfizer Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
      • Indianapolis, Indiana, United States, 46260
        • Pfizer Investigational Site
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66215
        • Pfizer Investigational Site
      • Pratt, Kansas, United States, 67124
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
      • Mount Sterling, Kentucky, United States, 40353
        • Pfizer Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Pfizer Investigational Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Pfizer Investigational Site
      • Brockton, Massachusetts, United States, 02301
        • Pfizer Investigational Site
      • Fall River, Massachusetts, United States, 02720
        • Pfizer Investigational Site
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Pfizer Investigational Site
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01610
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Pfizer Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
      • Edina, Minnesota, United States, 55435
        • Pfizer Investigational Site
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • Pfizer Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Pfizer Investigational Site
      • Columbia, Missouri, United States, 65212
        • Pfizer Investigational Site
      • Jefferson City, Missouri, United States, 65109
        • Pfizer Investigational Site
      • Saint Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89015
        • Pfizer Investigational Site
      • Henderson, Nevada, United States, 89014
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89119
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10454
        • Pfizer Investigational Site
      • Brooklyn, New York, United States, 11235
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10022-1009
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14610
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209-3734
        • Pfizer Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45249
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
      • Toledo, Ohio, United States, 43623
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Pfizer Investigational Site
    • Oregon
      • Bend, Oregon, United States, 97701
        • Pfizer Investigational Site
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97219
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97239
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Bethlehem, Pennsylvania, United States, 18015
        • Pfizer Investigational Site
      • Bridgeville, Pennsylvania, United States, 15017
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15216
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, United States, 19611-1124
        • Pfizer Investigational Site
      • Willow Grove, Pennsylvania, United States, 19090
        • Pfizer Investigational Site
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Pfizer Investigational Site
      • Lincoln, Rhode Island, United States, 02865
        • Pfizer Investigational Site
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29412
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pfizer Investigational Site
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • Pfizer Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
      • Milan, Tennessee, United States, 38358
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78759
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78758
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77701
        • Pfizer Investigational Site
      • Beaumont, Texas, United States, 77706
        • Pfizer Investigational Site
      • Bryan, Texas, United States, 77802
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site
      • DeSoto, Texas, United States, 75115
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77063
        • Pfizer Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • Pfizer Investigational Site
      • Nassau Bay, Texas, United States, 77058
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78213
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84107
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Pfizer Investigational Site
      • Charlottesville, Virginia, United States, 22911
        • Pfizer Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • Pfizer Investigational Site
    • Washington
      • Kirkland, Washington, United States, 98033
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98122
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99216
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Pfizer Investigational Site
      • Oregon, Wisconsin, United States, 53575
        • 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:

  • Male or female of any race, at least 18 years of age
  • Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

  • Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
  • Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
  • A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
  • History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing
Experimental: 2
Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing
Experimental: 3
Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing
Sham Comparator: 4
Drug: Placebo
0 mg oral tablet once a day dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the endpoint mean pain score
Time Frame: 14 weeks
14 weeks
Fibromyalgia Impact Questionnaire
Time Frame: 14 weeks
14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the endpoint mean sleep interference score
Time Frame: 14 weeks
14 weeks
Patient Global Impression of Change
Time Frame: 14 weeks
14 weeks
Multidimensional Assessment of Fatigue
Time Frame: 14 weeks
14 weeks
Hospital Anxiety and Depression Scale
Time Frame: 14 weeks
14 weeks
Short Form 36
Time Frame: 14 weeks
14 weeks
Sheehan Disability Score
Time Frame: 14 weeks
14 weeks
Pain Visual Analogue Scale
Time Frame: 14 weeks
14 weeks

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

December 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

January 29, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6061043

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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