Conditions: Chronic Pain
Keywords: Breakthrough pain Opioid-tolerant Chronic pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 323
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order). arm 2: This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Interventions: intervention 1: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Intervention descriptions: intervention 1: 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.

Protocol document: