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The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OraVescent Fentanyl | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the patients' quality of life through questionnaires | ||
| Assess the patients' overall medication preferences | ||
| Assess the patients' overall medication performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwendolyn Neibler, DO | Cephalon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedSearch | Calera | Alabama | 35040 | United States | ||
| Clinical Research Consultants, Inc. |
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| Hoover |
| Alabama |
| 35216 |
| United States |
| Arizona Research Center | Phoenix | Arizona | 85023 | United States |
| NEA Clinic | Jonesboro | Arkansas | 72404 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80909 | United States |
| Radiant Research-Daytona Beach | Daytona Beach | Florida | 32114 | United States |
| Advent Clinical Research Centers, Inc. | St. Petersburg | Florida | 33703 | United States |
| Gold Coast Research | Weston | Florida | 33331 | United States |
| Center for Prospective Outcome Studies, Inc. | Atlanta | Georgia | 30327 | United States |
| Advent Clinical Research Centers, Inc. | Atlanta | Georgia | 30342 | United States |
| Center for Prospective Outcome Studies, Inc. | Marietta | Georgia | 30060 | United States |
| North Fulton Regional Hospital Pain Center | Roswell | Georgia | 30076 | United States |
| Carmen Research | Smyrna | Georgia | 30080 | United States |
| Orthopedic Health Care | Boise | Idaho | 83702 | United States |
| Medisphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Tri-State Arthritis & Rheumatology Center, LLC | Evansville | Indiana | 47714 | United States |
| Iowa Pain Management Clinic, PC | Des Moines | Iowa | 50265 | United States |
| Mid-America Physiatrists, PA | Overland Park | Kansas | 66211 | United States |
| Capital Clinical Research Associates, LLC | Rockville | Maryland | 20852 | United States |
| Brigham Women's Hospital, Attn: Pain Trials Center | Boston | Massachusetts | 02115 | United States |
| MedVadis Research | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Medex Healthcare Research Center | St Louis | Missouri | 63108 | United States |
| Radiant Research - St. Louis | St Louis | Missouri | 63141 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Northshore University Hospital | Bethpage | New York | 11714 | United States |
| NYU Pain Management Center | New York | New York | 10016 | United States |
| Research Across America | New York | New York | 10022 | United States |
| The Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Southern Oregon Health & Wellness | Medford | Oregon | 97504 | United States |
| Clinical Research Center of Reading, LLP | West Reading | Pennsylvania | 19611 | United States |
| Healthstar Physicians | Morristown | Tennessee | 37813 | United States |
| Biopharma Research Associates | Sugar Land | Texas | 77479 | United States |
| Lifetree Clinical Research | Salt Lake City | Utah | 84106 | United States |
| Radiant Research | Salt Lake City | Utah | 84107 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Pain Management Center | South Burlington | Vermont | 05403 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| Rowan Research | Spokane | Washington | 99207 | United States |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D008881 | Migraine Disorders |
| D003929 | Diabetic Neuropathies |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D009437 | Neuralgia |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051270 | Headache Disorders, Primary |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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