A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia
1 other identifier
interventional
246
1 country
61
Brief Summary
The purpose of this study is to assess the safety and effectiveness of \[S,S\]-Reboxetine in patients with fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started Aug 2006
Shorter than P25 for phase_2 pain
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2006
CompletedFirst Posted
Study publicly available on registry
July 28, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedMay 15, 2013
May 1, 2013
7 months
July 26, 2006
May 14, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Weekly Average Pain Score from the Daily Pain Diary.
Secondary Outcomes (12)
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)
- +7 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (61)
Pfizer Investigational Site
Chandler, Arizona, 85225, United States
Pfizer Investigational Site
Phoenix, Arizona, 85007, United States
Pfizer Investigational Site
Phoenix, Arizona, 85013, United States
Pfizer Investigational Site
Sun City, Arizona, 85351, United States
Pfizer Investigational Site
Tucson, Arizona, 85741, United States
Pfizer Investigational Site
Auburn, California, 95602, United States
Pfizer Investigational Site
Orangevale, California, 95662, United States
Pfizer Investigational Site
Pismo Beach, California, 93449, United States
Pfizer Investigational Site
Walnut Creek, California, 94598, United States
Pfizer Investigational Site
Newark, Delaware, 19713, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Tampa, Florida, 33606, United States
Pfizer Investigational Site
Tampa, Florida, 33614, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Gurnee, Illinois, 60031, United States
Pfizer Investigational Site
Moline, Illinois, 61265, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46250, United States
Pfizer Investigational Site
Pratt, Kansas, 67124, United States
Pfizer Investigational Site
Lexington, Kentucky, 40509, United States
Pfizer Investigational Site
Fall River, Massachusetts, 02720, United States
Pfizer Investigational Site
Mansfield, Massachusetts, 02048, United States
Pfizer Investigational Site
Wellesley Hills, Massachusetts, 02481-2106, United States
Pfizer Investigational Site
Worcester, Massachusetts, 01610, United States
Pfizer Investigational Site
Jefferson City, Missouri, 65109, United States
Pfizer Investigational Site
Kansas City, Missouri, 64106, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Lincoln, Nebraska, 68516, United States
Pfizer Investigational Site
New York, New York, 10022-1009, United States
Pfizer Investigational Site
Cary, North Carolina, 27511, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28209-3734, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27609, United States
Pfizer Investigational Site
Minot, North Dakota, 58701, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45227, United States
Pfizer Investigational Site
Dayton, Ohio, 45402, United States
Pfizer Investigational Site
Toledo, Ohio, 43623, United States
Pfizer Investigational Site
Eugene, Oregon, 97401, United States
Pfizer Investigational Site
Medford, Oregon, 97504, United States
Pfizer Investigational Site
Altoona, Pennsylvania, 16602, United States
Pfizer Investigational Site
Bensalem, Pennsylvania, 19020, United States
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18015, United States
Pfizer Investigational Site
Camp Hill, Pennsylvania, 17011, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635-0909, United States
Pfizer Investigational Site
Cumberland, Rhode Island, 02864, United States
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572, United States
Pfizer Investigational Site
Milan, Tennessee, 38358, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Georgetown, Texas, 78626, United States
Pfizer Investigational Site
Houston, Texas, 77024, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Lake Jackson, Texas, 77566, United States
Pfizer Investigational Site
San Antonio, Texas, 78213, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84102, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23455, United States
Pfizer Investigational Site
Everett, Washington, 98201, United States
Pfizer Investigational Site
Tacoma, Washington, 98405, United States
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
Arnold LM, Chatamra K, Hirsch I, Stoker M. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 2010 Aug;32(9):1618-32. doi: 10.1016/j.clinthera.2010.08.003.
PMID: 20974319DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2006
First Posted
July 28, 2006
Study Start
August 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
May 15, 2013
Record last verified: 2013-05