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| ID | Type | Description | Link |
|---|---|---|---|
| A6061043 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 | Experimental |
| |
| 4 | Sham Comparator |
| |
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [S,S]-Reboxetine | Drug | 10 mg oral tablet once a day dosing |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the endpoint mean pain score | 14 weeks | |
| Fibromyalgia Impact Questionnaire | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the endpoint mean sleep interference score | 14 weeks | |
| Patient Global Impression of Change | 14 weeks | |
| Multidimensional Assessment of Fatigue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35242 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22275142 | Derived | Arnold LM, Hirsch I, Sanders P, Ellis A, Hughes B. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 2012 Jul;64(7):2387-97. doi: 10.1002/art.34390. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
0 mg oral tablet once a day dosing |
|
| [S,S]-Reboxetine | Drug | 4 mg oral tablet once a day dosing |
|
| [S,S]-Reboxetine | Drug | 8 mg oral tablet once a day dosing |
|
| 14 weeks |
| Hospital Anxiety and Depression Scale | 14 weeks |
| Short Form 36 | 14 weeks |
| Sheehan Disability Score | 14 weeks |
| Pain Visual Analogue Scale | 14 weeks |
| Huntsville |
| Alabama |
| 35802 |
| United States |
| Pfizer Investigational Site | Tallassee | Alabama | 36078 | United States |
| Pfizer Investigational Site | Chandler | Arizona | 85225 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85023 | United States |
| Pfizer Investigational Site | Tucson | Arizona | 85741 | United States |
| Pfizer Investigational Site | Carmichael | California | 95608 | United States |
| Pfizer Investigational Site | Elk Grove | California | 95758 | United States |
| Pfizer Investigational Site | Fullerton | California | 92835 | United States |
| Pfizer Investigational Site | Lafayette | California | 94549 | United States |
| Pfizer Investigational Site | Northridge | California | 91325 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | Roseville | California | 95661 | United States |
| Pfizer Investigational Site | Sacramento | California | 95816 | United States |
| Pfizer Investigational Site | Sacramento | California | 95823 | United States |
| Pfizer Investigational Site | San Jose | California | 95124 | United States |
| Pfizer Investigational Site | Santa Ana | California | 92705 | United States |
| Pfizer Investigational Site | New London | Connecticut | 06320 | United States |
| Pfizer Investigational Site | Brooksville | Florida | 34601 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32205 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32216 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32223 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32257 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Sarasota | Florida | 34233 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33709 | United States |
| Pfizer Investigational Site | Sunrise | Florida | 33351 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33606 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33614 | United States |
| Pfizer Investigational Site | Venice | Florida | 34292 | United States |
| Pfizer Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Pfizer Investigational Site | Winter Haven | Florida | 33880 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Aurora | Illinois | 60504 | United States |
| Pfizer Investigational Site | Gurnee | Illinois | 60031 | United States |
| Pfizer Investigational Site | Moline | Illinois | 61265 | United States |
| Pfizer Investigational Site | Oak Brook | Illinois | 60523 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Pfizer Investigational Site | Indianapolis | Indiana | 46260 | United States |
| Pfizer Investigational Site | Dubuque | Iowa | 52001 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66215 | United States |
| Pfizer Investigational Site | Pratt | Kansas | 67124 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40509 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40213 | United States |
| Pfizer Investigational Site | Madisonville | Kentucky | 42431 | United States |
| Pfizer Investigational Site | Mount Sterling | Kentucky | 40353 | United States |
| Pfizer Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pfizer Investigational Site | Wheaton | Maryland | 20902 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02135 | United States |
| Pfizer Investigational Site | Brockton | Massachusetts | 02301 | United States |
| Pfizer Investigational Site | Fall River | Massachusetts | 02720 | United States |
| Pfizer Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| Pfizer Investigational Site | Watertown | Massachusetts | 02472 | United States |
| Pfizer Investigational Site | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Pfizer Investigational Site | Worcester | Massachusetts | 01610 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48103 | United States |
| Pfizer Investigational Site | Chaska | Minnesota | 55318 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | United States |
| Pfizer Investigational Site | Olive Branch | Mississippi | 38654 | United States |
| Pfizer Investigational Site | Columbia | Missouri | 65203 | United States |
| Pfizer Investigational Site | Columbia | Missouri | 65212 | United States |
| Pfizer Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68134 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89014 | United States |
| Pfizer Investigational Site | Henderson | Nevada | 89015 | United States |
| Pfizer Investigational Site | Las Vegas | Nevada | 89119 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Albany | New York | 12205 | United States |
| Pfizer Investigational Site | Brooklyn | New York | 11235 | United States |
| Pfizer Investigational Site | New York | New York | 10021 | United States |
| Pfizer Investigational Site | New York | New York | 10022-1009 | United States |
| Pfizer Investigational Site | Rochester | New York | 14610 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | The Bronx | New York | 10454 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28209-3734 | United States |
| Pfizer Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45249 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44122 | United States |
| Pfizer Investigational Site | Columbus | Ohio | 43213 | United States |
| Pfizer Investigational Site | Dayton | Ohio | 45408 | United States |
| Pfizer Investigational Site | Toledo | Ohio | 43623 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Bend | Oregon | 97701 | United States |
| Pfizer Investigational Site | Eugene | Oregon | 97401 | United States |
| Pfizer Investigational Site | Medford | Oregon | 97504 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97219 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97239 | United States |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Pfizer Investigational Site | Bethlehem | Pennsylvania | 18015 | United States |
| Pfizer Investigational Site | Bridgeville | Pennsylvania | 15017 | United States |
| Pfizer Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15216 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Pfizer Investigational Site | West Reading | Pennsylvania | 19611-1124 | United States |
| Pfizer Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| Pfizer Investigational Site | Cumberland | Rhode Island | 02864 | United States |
| Pfizer Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29412 | United States |
| Pfizer Investigational Site | Bristol | Tennessee | 37620 | United States |
| Pfizer Investigational Site | Jackson | Tennessee | 38305 | United States |
| Pfizer Investigational Site | Johnson City | Tennessee | 37601 | United States |
| Pfizer Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Pfizer Investigational Site | Milan | Tennessee | 38358 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Austin | Texas | 78758 | United States |
| Pfizer Investigational Site | Austin | Texas | 78759 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77701 | United States |
| Pfizer Investigational Site | Beaumont | Texas | 77706 | United States |
| Pfizer Investigational Site | Bryan | Texas | 77802 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | DeSoto | Texas | 75115 | United States |
| Pfizer Investigational Site | Houston | Texas | 77063 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | Nassau Bay | Texas | 77058 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78213 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78229 | United States |
| Pfizer Investigational Site | Ogden | Utah | 84405 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Pfizer Investigational Site | Arlington | Virginia | 22205 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | 22911 | United States |
| Pfizer Investigational Site | Virginia Beach | Virginia | 23455 | United States |
| Pfizer Investigational Site | Kirkland | Washington | 98033 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98104 | United States |
| Pfizer Investigational Site | Seattle | Washington | 98122 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99216 | United States |
| Pfizer Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Pfizer Investigational Site | Oregon | Wisconsin | 53575 | United States |
| Pfizer Investigational Site | Kelowna | British Columbia | V1Y 2H4 | Canada |
| Pfizer Investigational Site | Bathurst | New Brunswick | E2A 4X7 | Canada |
| Pfizer Investigational Site | Moncton | New Brunswick | E1G 1A7 | Canada |
| Pfizer Investigational Site | Hawkesbury | Ontario | K6A 1A1 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1V 3M7 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C524178 | O-methyl reboxetine |
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