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Fentanyl Buccal Compared With Immediate-Release Oxycodone · 1 trial · 1 indication
Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry.
| Arm | Type | Description |
|---|---|---|
| Fentanyl Buccal Tablets (FBT) | EXPERIMENTAL | This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order). |
| Oxycodone | 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). |
| Name | Type | Description |
|---|---|---|
| Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone | DRUG | 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, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration. |
Inclusion Criteria: * The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer. * The patien...
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
It is a Phase 3 clinical study comparing fentanyl buccal tablets with immediate-release oxycodone for managing breakthrough pain in patients with chronic pain. The trial, NCT00463047, enrolled 323 participants in the United States and has been completed. It was a randomized, double-blind, active-controlled study in adults aged 18 years and older.
Fentanyl buccal tablets are being studied for the management of breakthrough pain in patients with chronic pain. The Phase 3 trial NCT00463047 evaluated this use by comparing fentanyl buccal tablets with immediate-release oxycodone. The study enrolled 323 adults with chronic pain and has been completed.
Fentanyl buccal targets OPRM1, the mu-opioid receptor, and acts as an agonist at this receptor. This mechanism underlies its evaluation for breakthrough pain in chronic pain patients. The Phase 3 study NCT00463047 compared it with immediate-release oxycodone in 323 enrolled participants.
Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of the fentanyl buccal compared with immediate-release oxycodone program. The company sponsored the Phase 3 trial NCT00463047 evaluating fentanyl buccal tablets against immediate-release oxycodone for breakthrough pain in chronic pain.
The fentanyl buccal compared with immediate-release oxycodone program is in Phase 3. The single registered trial, NCT00463047, is a completed Phase 3 study that enrolled 323 participants. It was randomized, double-blind, and active-controlled, evaluating fentanyl buccal tablets against immediate-release oxycodone for breakthrough pain in chronic pain.
The program includes one clinical trial, NCT00463047, titled Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain. This completed Phase 3 study enrolled 323 adults with chronic pain across sites in the United States and used a randomized, double-blind, active-controlled design.