Conditions: Dental Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.

Detailed description:

Arms:
arm 1: Oxycodone 5-mg oral capsule and 2 buccal placebo films arm 2: Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule arm 3: Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule arm 4: Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule arm 5: Oral placebo capsule and 2 buccal placebo films

Interventions: intervention 1: Oxycodone intervention 2: Buprenorphine intervention 3: Placebo Film intervention 4: Placebo Capsule
Intervention descriptions: intervention 1: Single-dose of over-encapsulated oral 5-mg oxycodone capsule intervention 2: Single-dose of buprenorphine HCl buccal film intervention 3: Single-dose of placebo buccal film intervention 4: Single-dose of oral placebo capsule

Protocol document: