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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
Show 45 Study Locations
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 |