Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioDelivery Sciences International; Endo Pharmaceuticals
• Treatments: Buprenorphine; Oxycodone

Criteria

Inclusion Criteria:

• extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone

• males or non-pregnant females, aged 18 to 45 years

• good general health and capable of providing informed consent

Exclusion Criteria:

• history of substance abuse or dependence

• positive urine toxicology screen or alcohol breath test

• history of hypersensitivity to or allergy to any study drug

• donation of blood within prior 30 days

• use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours