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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00463047 |
Purpose
Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment |
| Official Title: | A Randomized, Double-Blind, Active-Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patient With Chronic Pain |
| Enrollment: | 324 |
| Study Start Date: | June 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).
|
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Alabama Clinical Therapeutics | |
| Birmingham, Alabama, United States, 35235 | |
| Birmingham Pain Center | |
| Birmingham, Alabama, United States, 35244 | |
| United States, Arizona | |
| Desert Pain & Rehab Specialists/Redpoint Research | |
| Phoenix, Arizona, United States, 85029 | |
| Hope Research Institute | |
| Phoenix, Arizona, United States, 85050 | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Samaritan Center for Medical Research, Med. Group | |
| Los Gatos, California, United States, 95032 | |
| Lovelace Scientific Resources, Inc. | |
| Beverly Hills, California, United States, 90211 | |
| City of Hope National Medical Center | |
| Duarte, California, United States, 91010 | |
| United States, Connecticut | |
| Advanced Diagnostic Pain Treatment Center, PC | |
| New Haven, Connecticut, United States, 06511 | |
| United States, Florida | |
| Lovelace Scientific Resources, Inc. | |
| Sarasota, Florida, United States, 34233 | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Compass Research | |
| Orlando, Florida, United States, 32806 | |
| Stedman Clinical Trials, LLC | |
| Tampa, Florida, United States, 33613 | |
| Clinical Research of Tampa Bay, Inc. | |
| Spring Hill, Florida, United States, 34609 | |
| AvivoClin Clinical Services | |
| Port Orange, Florida, United States, 32127 | |
| United States, Georgia | |
| DrugStudies America | |
| Marietta, Georgia, United States, 30066 | |
| Taylor Research, LLC | |
| Marietta, Georgia, United States, 30060 | |
| Center for Prospective Outcome Studies, Inc. | |
| Atlanta, Georgia, United States, 30327 | |
| North Georgia Premier Research | |
| Dawnsonville, Georgia, United States, 30534 | |
| United States, Indiana | |
| Rehabilitation Associates of Indiana | |
| Indianapolis, Indiana, United States, 46250 | |
| Tristate Arthritis & Rheumatology Center, LLC | |
| Evansville, Indiana, United States, 47714 | |
| United States, Iowa | |
| Integrated Clinical Trial Services, Inc. | |
| West Des Moines, Iowa, United States, 50265 | |
| United States, Kansas | |
| International Clinical Research Institute, Inc. | |
| Overland Park, Kansas, United States, 66211 | |
| Kansas City Bone & Joint Clinic, Inc. | |
| Overland Park, Kansas, United States, 66211 | |
| United States, Louisiana | |
| Willis-Knighton Pain Management Center | |
| Shreveport, Louisiana, United States, 71103 | |
| United States, Maryland | |
| Mid Atlantic Pain Medicine Center | |
| Pikesville, Maryland, United States, 21208 | |
| The Rehabilitation Team West | |
| Baltimore, Maryland, United States, 21228 | |
| United States, New Jersey | |
| Englewood Hospital and Medical Center | |
| Englewood, New Jersey, United States, 07631 | |
| United States, New Mexico | |
| Lovelace Scientific Resources, Inc. | |
| Albuquerque, New Mexico, United States, 87108 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Metropolitan Hospital Center | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| PharmQuest | |
| Greensboro, North Carolina, United States, 27401 | |
| Raleigh Neurology Associate | |
| Raleigh, North Carolina, United States, 27607 | |
| Peters Medical Research | |
| High Point, North Carolina, United States, 27262 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Columbus Clinical Research | |
| Columbus, Ohio, United States, 43213 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| Allegheny Pain Management | |
| Altoona, Pennsylvania, United States, 16602 | |
| United States, South Carolina | |
| Greenville Pharmaceutical | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| Comprehensive Pain Specialists, PLLC | |
| Hendersonville, Tennessee, United States, 37075 | |
| United States, Texas | |
| Consultants in Pain Research | |
| San Antonio, Texas, United States, 78209 | |
| InVisions Consultants, LLC | |
| San Antonio, Texas, United States, 78218 | |
| United States, Washington | |
| Northwest Clinical Research Center | |
| Bellevue, Washington, United States, 98004 | |
| United States, West Virginia | |
| The Center for Pain Relief | |
| Charleston, West Virginia, United States, 25301 | |
More Information
| Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
| Study ID Numbers: | C25608/3055/BP/MN |
| Study First Received: | February 8, 2007 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00463047 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Breakthrough pain Opioid-tolerant Chronic pain |
|
Anesthetics, Intravenous Fentanyl Nervous System Diseases Oxycodone Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pain Narcotics Pharmacologic Actions |
Adjuvants, Anesthesia Signs and Symptoms Anesthetics, General Sensory System Agents Therapeutic Uses Neurologic Manifestations Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid |