Conditions: Chronic Pain
Keywords: Breakthrough Pain Opioid-tolerant Chronic Pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 213
Healthy volunteers: no

Brief summary:
Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.

Detailed description:

Arms:
arm 1: This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid. arm 2: This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.

Interventions: intervention 1: Fentanyl Buccal Tablet intervention 2: Immediate release oxycodone
Intervention descriptions: intervention 1: FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.

The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).

For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician. intervention 2: Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.

The maximum single dose would be 60 mg (4 capsules).

Protocol document: