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Sponsored by: |
Cephalon |
Information provided by: | Cephalon |
ClinicalTrials.gov Identifier: | NCT00214955 |
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Neuropathic Pain
Condition | Intervention | Phase |
Chronic Neuropathic Pain |
Drug: ORAVESCENT Fentanyl Citrate |
Phase III |
Drug Information available for: | Fentanyl Citrate Fentanyl Citric acid Sodium Citrate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Neuropathic Pain |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
United States, Arkansas | |||||
Clopton Clinic | |||||
Jonesboro, Arkansas, United States, 72401 | |||||
United States, California | |||||
San Diego Arthritis Medical | |||||
San Diego, California, United States, 92106 | |||||
Vertex Clinical Research, Inc. | |||||
Bakersfield, California, United States, 93311 | |||||
United States, Florida | |||||
Clinical Pharmacology Services | |||||
Tampa, Florida, United States, 33617 | |||||
Florida Institute of Medical R | |||||
Jacksonville, Florida, United States, 32207 | |||||
Gold Coast Research | |||||
Weston, Florida, United States, 33331 | |||||
Clinical Research of W Florida | |||||
Clearwater, Florida, United States, 33765 | |||||
United States, Georgia | |||||
Center for Prospective Outcome | |||||
Marietta, Georgia, United States, 30060 | |||||
Georgia Medical Research | |||||
Marietta, Georgia, United States, 30060 | |||||
United States, Illinois | |||||
American Medical Research | |||||
Oak Brook, Illinois, United States, 60523 | |||||
American Medical Research | |||||
Chicago, Illinois, United States, 60616 | |||||
United States, Indiana | |||||
American Medical Research | |||||
Valparaiso, Indiana, United States, 46383 | |||||
United States, Iowa | |||||
Iowa Pain Management Clinic, P | |||||
Des Moines, Iowa, United States, 50265 | |||||
United States, Kansas | |||||
Mid America Physiatrists, PA | |||||
Overland Park, Kansas, United States, 66211 | |||||
United States, Louisiana | |||||
Best Clinical Trial, Inc. | |||||
New Orleans, Louisiana, United States, 70115 | |||||
United States, North Carolina | |||||
PharmQuest | |||||
Greensboro, North Carolina, United States, 27401 | |||||
United States, Washington | |||||
Northwest Clinical Research | |||||
Bellevue, Washington, United States, 98004 |
Cephalon |
Study ID Numbers: | C25608/3041/BP/US |
First Received: | September 14, 2005 |
Last Updated: | September 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00214955 |
Health Authority: | United States: Food and Drug Administration |
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