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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00357825
First received: July 26, 2006
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention Phase
Pain
Drug: [S,S]-Reboxetine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Weekly Average Pain Score from the Daily Pain Diary.

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) Total Score
  • Patient Global Impression of Change
  • Short-Form 36 Health Survey (SF 36)
  • Sheehan Disability Scale
  • 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)
  • Short-Form McGill Pain Questionnaire (SF-MPQ)
  • Fibromyalgia Health Assessment Questionnaire (F-HAQ)
  • Safety and Tolerability
  • Exposure Response Relationship Between Daily Dose and Daily Pain Score

Estimated Enrollment: 246
Study Start Date: August 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357825

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
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
United States, California
Pfizer Investigational Site
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
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Ocala, Florida, United States, 34474
Pfizer Investigational Site
Ocala, Florida, United States, 34471
Pfizer Investigational Site
Tampa, Florida, United States, 33606
Pfizer Investigational Site
Tampa, Florida, United States, 33614
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
Pfizer Investigational Site
Moline, Illinois, United States, 61265
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46250
United States, Kansas
Pfizer Investigational Site
Pratt, Kansas, United States, 67124
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40509
United States, Massachusetts
Pfizer Investigational Site
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
United States, Missouri
Pfizer Investigational Site
Jefferson City, Missouri, United States, 65109
Pfizer Investigational Site
Kansas City, Missouri, United States, 64106
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
Pfizer Investigational Site
Lincoln, Nebraska, United States, 68516
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10022-1009
United States, North Carolina
Pfizer Investigational Site
Cary, North Carolina, United States, 27511
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28209-3734
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Pfizer Investigational Site
Minot, North Dakota, United States, 58701
United States, Ohio
Pfizer Investigational Site
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
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
Pfizer Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Pfizer Investigational Site
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
United States, Rhode Island
Pfizer Investigational Site
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Pfizer Investigational Site
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Pfizer Investigational Site
Milan, Tennessee, United States, 38358
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Georgetown, Texas, United States, 78626
Pfizer Investigational Site
Houston, Texas, United States, 77024
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78213
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
United States, Virginia
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23455
United States, Washington
Pfizer Investigational Site
Everett, Washington, United States, 98201
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00357825     History of Changes
Other Study ID Numbers: A6061034
Study First Received: July 26, 2006
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014