A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00357825
Collaborator
(none)
246
61
7
4
0.6
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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
Study Start Date
:
Aug 1, 2006
Actual Primary Completion Date
:
Mar 1, 2007
Actual Study Completion Date
:
Mar 1, 2007
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Chandler | Arizona | United States | 85225 |
| 2 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85007 |
| 3 | Pfizer Investigational Site | Phoenix | Arizona | United States | 85013 |
| 4 | Pfizer Investigational Site | Sun City | Arizona | United States | 85351 |
| 5 | Pfizer Investigational Site | Tucson | Arizona | United States | 85741 |
| 6 | Pfizer Investigational Site | Auburn | California | United States | 95602 |
| 7 | Pfizer Investigational Site | Orangevale | California | United States | 95662 |
| 8 | Pfizer Investigational Site | Pismo Beach | California | United States | 93449 |
| 9 | Pfizer Investigational Site | Walnut Creek | California | United States | 94598 |
| 10 | Pfizer Investigational Site | Newark | Delaware | United States | 19713 |
| 11 | Pfizer Investigational Site | DeLand | Florida | United States | 32720 |
| 12 | Pfizer Investigational Site | Ocala | Florida | United States | 34471 |
| 13 | Pfizer Investigational Site | Ocala | Florida | United States | 34474 |
| 14 | Pfizer Investigational Site | Tampa | Florida | United States | 33606 |
| 15 | Pfizer Investigational Site | Tampa | Florida | United States | 33614 |
| 16 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 17 | Pfizer Investigational Site | Gurnee | Illinois | United States | 60031 |
| 18 | Pfizer Investigational Site | Moline | Illinois | United States | 61265 |
| 19 | Pfizer Investigational Site | Indianapolis | Indiana | United States | 46250 |
| 20 | Pfizer Investigational Site | Pratt | Kansas | United States | 67124 |
| 21 | Pfizer Investigational Site | Lexington | Kentucky | United States | 40509 |
| 22 | Pfizer Investigational Site | Fall River | Massachusetts | United States | 02720 |
| 23 | Pfizer Investigational Site | Mansfield | Massachusetts | United States | 02048 |
| 24 | Pfizer Investigational Site | Wellesley Hills | Massachusetts | United States | 02481-2106 |
| 25 | Pfizer Investigational Site | Worcester | Massachusetts | United States | 01610 |
| 26 | Pfizer Investigational Site | Jefferson City | Missouri | United States | 65109 |
| 27 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64106 |
| 28 | Pfizer Investigational Site | St. Louis | Missouri | United States | 63141 |
| 29 | Pfizer Investigational Site | Lincoln | Nebraska | United States | 68516 |
| 30 | Pfizer Investigational Site | New York | New York | United States | 10022-1009 |
| 31 | Pfizer Investigational Site | Cary | North Carolina | United States | 27511 |
| 32 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28209-3734 |
| 33 | Pfizer Investigational Site | Charlotte | North Carolina | United States | 28210 |
| 34 | Pfizer Investigational Site | Raleigh | North Carolina | United States | 27609 |
| 35 | Pfizer Investigational Site | Minot | North Dakota | United States | 58701 |
| 36 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 37 | Pfizer Investigational Site | Cincinnati | Ohio | United States | 45227 |
| 38 | Pfizer Investigational Site | Dayton | Ohio | United States | 45402 |
| 39 | Pfizer Investigational Site | Toledo | Ohio | United States | 43623 |
| 40 | Pfizer Investigational Site | Eugene | Oregon | United States | 97401 |
| 41 | Pfizer Investigational Site | Medford | Oregon | United States | 97504 |
| 42 | Pfizer Investigational Site | Altoona | Pennsylvania | United States | 16602 |
| 43 | Pfizer Investigational Site | Bensalem | Pennsylvania | United States | 19020 |
| 44 | Pfizer Investigational Site | Bethlehem | Pennsylvania | United States | 18015 |
| 45 | Pfizer Investigational Site | Camp Hill | Pennsylvania | United States | 17011 |
| 46 | Pfizer Investigational Site | Duncansville | Pennsylvania | United States | 16635-0909 |
| 47 | Pfizer Investigational Site | Cumberland | Rhode Island | United States | 02864 |
| 48 | Pfizer Investigational Site | Myrtle Beach | South Carolina | United States | 29572 |
| 49 | Pfizer Investigational Site | Milan | Tennessee | United States | 38358 |
| 50 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 51 | Pfizer Investigational Site | Georgetown | Texas | United States | 78626 |
| 52 | Pfizer Investigational Site | Houston | Texas | United States | 77024 |
| 53 | Pfizer Investigational Site | Houston | Texas | United States | 77030 |
| 54 | Pfizer Investigational Site | Lake Jackson | Texas | United States | 77566 |
| 55 | Pfizer Investigational Site | San Antonio | Texas | United States | 78213 |
| 56 | Pfizer Investigational Site | San Antonio | Texas | United States | 78229 |
| 57 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84102 |
| 58 | Pfizer Investigational Site | Virginia Beach | Virginia | United States | 23455 |
| 59 | Pfizer Investigational Site | Everett | Washington | United States | 98201 |
| 60 | Pfizer Investigational Site | Tacoma | Washington | United States | 98405 |
| 61 | Pfizer Investigational Site | Milwaukee | Wisconsin | United States | 53209 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00357825
Other Study ID Numbers:
- A6061034
First Posted:
Jul 28, 2006
Last Update Posted:
May 15, 2013
Last Verified:
May 1, 2013