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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00607256 |
Purpose
To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia |
Drug: [S,S]-reboxetine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Multi-Center, Long-Term, Open-Label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia |
| Estimated Enrollment: | 500 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Open Label: Experimental |
Drug: [S,S]-reboxetine
S_S reboxetine dosed daily.
|
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, California | |
| Pfizer Investigational Site | |
| Orangevale, California, United States, 95662 | |
| Pfizer Investigational Site | |
| Santa Ana, California, United States, 92705 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80239 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| West Palm Beach, Florida, United States, 33407 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Moline, Illinois, United States, 61265 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Prairie Village, Kansas, United States, 66206 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| Pfizer Investigational Site | |
| St Louis, Missouri, United States, 63141 | |
| Pfizer Investigational Site | |
| Jefferson City, Missouri, United States, 65109 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Kenilworth, New Jersey, United States, 07033 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Staten Island, New York, United States, 10312 | |
| Pfizer Investigational Site | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Cary, North Carolina, United States, 27511 | |
| 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 | |
| Marion, Ohio, United States, 43302 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Bethlehem, Pennsylvania, United States, 18015 | |
| Pfizer Investigational Site | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Cumberland, Rhode Island, United States, 02864 | |
| Pfizer Investigational Site | |
| Cranston, Rhode Island, United States, 02920 | |
| 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 | |
| Pfizer Investigational Site | |
| Greer, South Carolina, United States, 29651 | |
| Pfizer Investigational Site | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78213 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77063 | |
| 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, 78229 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23294 | |
| Pfizer Investigational Site | |
| Virginia Beach, Virginia, United States, 23455 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99216 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Belgium | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1070 | |
| Pfizer Investigational Site | |
| Pellenberg, Belgium, 3212 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 2H4 | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Moncton, New Brunswick, Canada, E1G 1A7 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Pfizer Investigational Site | |
| Pointe Claire, Quebec, Canada, H9R 3J1 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Zlin, Czech Republic, 760 01 | |
| Pfizer Investigational Site | |
| Praha 2, Czech Republic, 128 50 | |
| Pfizer Investigational Site | |
| Hlucin, Czech Republic, 748 01 | |
| Pfizer Investigational Site | |
| Pardubice, Czech Republic, 530 02 | |
| France | |
| Pfizer Investigational Site | |
| Nice Cedex 1, France, 06002 | |
| Pfizer Investigational Site | |
| Paris Cedex 04, France, 75181 | |
| France, Cedex | |
| Pfizer Investigational Site | |
| Lille, Cedex, France, 59037 | |
| Germany | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10117 | |
| Pfizer Investigational Site | |
| Mannheim, Germany, 68161 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 14109 | |
| Pfizer Investigational Site | |
| Wiesbaden, Germany, 65189 | |
| Pfizer Investigational Site | |
| Goeppingen, Germany, 73033 | |
| Pfizer Investigational Site | |
| Eichstaett, Germany, 85072 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80336 | |
| Pfizer Investigational Site | |
| Hamburg, Germany, 20095 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Gwangju, Korea, Republic of, 501-757 | |
| Korea, Republic of, Kyeongki-do | |
| Pfizer Investigational Site | |
| Suwon-si, Kyeongki-do, Korea, Republic of, 442-712 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Leeuwarden, Netherlands, 8934 AD | |
| Pfizer Investigational Site | |
| Emmen, Netherlands, 7824 AA | |
| Pfizer Investigational Site | |
| BREDA, Netherlands, 4819 EV | |
| South Africa, Gauteng | |
| Pfizer Investigational Site | |
| Boksburg, Gauteng, South Africa, 1462 | |
| South Africa, Gauteng Province | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng Province, South Africa, 0001 | |
| South Africa, Western Cape | |
| Pfizer Investigational Site | |
| Parow, Western Cape, South Africa, 7500 | |
| Pfizer Investigational Site | |
| Panorama, Western Cape, South Africa, 7500 | |
| Sweden | |
| Pfizer Investigational Site | |
| Molndal, Sweden, 431 37 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 115 22 | |
| Pfizer Investigational Site | |
| Stockholm, Sweden, 182 88 | |
| Pfizer Investigational Site | |
| Goteborg, Sweden, 412 55 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Colchester, United Kingdom, C04 5JL | |
| Pfizer Investigational Site | |
| Dudley, West Midlands, United Kingdom, DY1 2HQ | |
| Pfizer Investigational Site | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Pfizer Investigational Site | |
| Greenock, United Kingdom, PA16 0XN | |
| Pfizer Investigational Site | |
| Derby, United Kingdom, DE1 2QY | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A6061046 |
| Study First Received: | January 23, 2008 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607256 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
