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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00612170 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: [S,S]-Reboxetine Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 1129 |
| Study Start Date: | December 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 3: Experimental |
Drug: [S,S]-Reboxetine
10 mg oral tablet once a day dosing
|
| 4: Sham Comparator |
Drug: Placebo
0 mg oral tablet once a day dosing
|
| 1: Experimental |
Drug: [S,S]-Reboxetine
4 mg oral tablet once a day dosing
|
| 2: Experimental |
Drug: [S,S]-Reboxetine
8 mg oral tablet once a day dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35242 | |
| Pfizer Investigational Site | |
| Tallassee, Alabama, United States, 36078 | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35802 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85023 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85741 | |
| Pfizer Investigational Site | |
| Chandler, Arizona, United States, 85225 | |
| United States, California | |
| Pfizer Investigational Site | |
| Lafayette, California, United States, 94549 | |
| Pfizer Investigational Site | |
| Fullerton, California, United States, 92835 | |
| Pfizer Investigational Site | |
| Carmichael, California, United States, 95608 | |
| Pfizer Investigational Site | |
| Santa Ana, California, United States, 92705 | |
| Pfizer Investigational Site | |
| Roseville, California, United States, 95661 | |
| Pfizer Investigational Site | |
| Elk Grove, California, United States, 95758 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95816 | |
| Pfizer Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Pfizer Investigational Site | |
| Northridge, California, United States, 91325 | |
| Pfizer Investigational Site | |
| Sacramento, California, United States, 95823 | |
| Pfizer Investigational Site | |
| San Jose, California, United States, 95124 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New London, Connecticut, United States, 06320 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33709 | |
| Pfizer Investigational Site | |
| Brooksville, Florida, United States, 34601 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34233 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| Pfizer Investigational Site | |
| Sunrise, Florida, United States, 33351 | |
| Pfizer Investigational Site | |
| Winter Haven, Florida, United States, 33880 | |
| Pfizer Investigational Site | |
| Venice, Florida, United States, 34292 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32223 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32257 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32205 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| 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 | |
| Aurora, Illinois, United States, 60504 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46250 | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Iowa | |
| Pfizer Investigational Site | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| Pfizer Investigational Site | |
| Pratt, Kansas, United States, 67124 | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66215 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Mt. Sterling, Kentucky, United States, 40353 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| Pfizer Investigational Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02720 | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02135 | |
| Pfizer Investigational Site | |
| Watertown, Massachusetts, United States, 02472 | |
| Pfizer Investigational Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| Pfizer Investigational Site | |
| Brockton, Massachusetts, United States, 02301 | |
| Pfizer Investigational Site | |
| Worcester, Massachusetts, United States, 01610 | |
| Pfizer Investigational Site | |
| Wellesley Hills, Massachusetts, United States, 02481-2106 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48103 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Rochester, Minnesota, United States, 55905 | |
| Pfizer Investigational Site | |
| Chaska, Minnesota, United States, 55318 | |
| Pfizer Investigational Site | |
| Edina, Minnesota, United States, 55435 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Columbia, Missouri, United States, 65203 | |
| Pfizer Investigational Site | |
| Columbia, Missouri, United States, 65212 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68134 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89119 | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89014 | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89015 | |
| United States, New Mexico | |
| Pfizer Investigational Site | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10022-1009 | |
| Pfizer Investigational Site | |
| Albany, New York, United States, 12205 | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10454 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14610 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Salisbury, North Carolina, United States, 28144 | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28209-3734 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45219 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45249 | |
| Pfizer Investigational Site | |
| Toledo, Ohio, United States, 43623 | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43213 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44122 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45408 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97219 | |
| Pfizer Investigational Site | |
| Bend, Oregon, United States, 97701 | |
| Pfizer Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| Pfizer Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pfizer Investigational Site | |
| Bridgeville, Pennsylvania, United States, 15017 | |
| Pfizer Investigational Site | |
| West Reading, Pennsylvania, United States, 19611-1124 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15216 | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| Pfizer Investigational Site | |
| Willow Grove, Pennsylvania, United States, 19090 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15243 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Cumberland, Rhode Island, United States, 02864 | |
| Pfizer Investigational Site | |
| Warwick, Rhode Island, United States, 02886 | |
| Pfizer Investigational Site | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29412 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| Pfizer Investigational Site | |
| Bristol, Tennessee, United States, 37620 | |
| Pfizer Investigational Site | |
| Kingsport, Tennessee, United States, 37660 | |
| Pfizer Investigational Site | |
| Milan, Tennessee, United States, 38358 | |
| Pfizer Investigational Site | |
| Jackson, Tennessee, United States, 38305 | |
| Pfizer Investigational Site | |
| Johnson City, Tennessee, United States, 37601 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78213 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78759 | |
| Pfizer Investigational Site | |
| Lake Jackson, Texas, United States, 77566 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78758 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| DeSoto, Texas, United States, 75115 | |
| Pfizer Investigational Site | |
| Bryan, Texas, United States, 77802 | |
| Pfizer Investigational Site | |
| Nassau Bay, Texas, United States, 77058 | |
| Pfizer Investigational Site | |
| Beaumont, Texas, United States, 77701 | |
| Pfizer Investigational Site | |
| Beaumont, Texas, United States, 77706 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77063 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Ogden, Utah, United States, 84405 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Viginia Beach, Virginia, United States, 23455 | |
| Pfizer Investigational Site | |
| Charlottesville, Virginia, United States, 22911 | |
| Pfizer Investigational Site | |
| Arlington, Virginia, United States, 22205 | |
| Pfizer Investigational Site | |
| Virginia Beach, Virginia, United States, 23455 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| 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 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Pfizer Investigational Site | |
| Oregon, Wisconsin, United States, 53575 | |
| Canada | |
| Pfizer Investigational Site | |
| Quebec, Canada, G1V 3M7 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 2H4 | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Bathurst, New Brunswick, Canada, E2A 4X7 | |
| Pfizer Investigational Site | |
| Moncton, New Brunswick, Canada, E1G 1A7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M3H 5S4 | |
| Pfizer Investigational Site | |
| Hawkesbury, Ontario, Canada, K6A 1A1 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Pfizer Investigational Site | |
| Pointe Claire, Quebec, Canada, H9R 3J1 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6061043, A6061043 |
| Study First Received: | January 29, 2008 |
| Last Updated: | July 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00612170 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Fibromyalgia Myofascial Pain Syndromes Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs |
Rheumatic Diseases Pharmacologic Actions Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Therapeutic Uses Central Nervous System Agents Antidepressive Agents Reboxetine |
