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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00214955 |
Purpose
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| United States, Arkansas | |
| Clopton Clinic | |
| Jonesboro, Arkansas, United States, 72401 | |
| United States, California | |
| Vertex Clinical Research, Inc. | |
| Bakersfield, California, United States, 93311 | |
| San Diego Arthritis Medical | |
| San Diego, California, United States, 92106 | |
| United States, Florida | |
| Clinical Research of W Florida | |
| Clearwater, Florida, United States, 33765 | |
| Florida Institute of Medical R | |
| Jacksonville, Florida, United States, 32207 | |
| Clinical Pharmacology Services | |
| Tampa, Florida, United States, 33617 | |
| Gold Coast Research | |
| Weston, Florida, United States, 33331 | |
| 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 | |
| Chicago, Illinois, United States, 60616 | |
| American Medical Research | |
| Oak Brook, Illinois, United States, 60523 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00214955 History of Changes |
| Other Study ID Numbers: | C25608/3041/BP/US |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 11, 2006 |
| Health Authority: | United States: Food and Drug Administration |
|
Neuralgia Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Citric Acid Fentanyl Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents |
Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia Central Nervous System Agents Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |