A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction

NCT00941304 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	BioDelivery Sciences International
Phase	Phase 2
Status	COMPLETED
Enrolment	153
Start date	2009-08
Completion	2009-11

Conditions

• Dental Pain

Interventions

• Oxycodone
• Buprenorphine
• Placebo Film
• Placebo Capsule

Primary outcomes

• Sum of Pain Intensity Difference From Baseline to 8 Hours — Baseline, 8 hours
  Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"

Countries

United States