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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Pain

In brief

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

Key facts

Study ID

NCT00941304

Run by

BioDelivery Sciences International

People needed

153

Starts

2009-08-01

Expected to finish

2009-11-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Premier Research Group Limited — Austin, Texas, United States
• Donald P. Bandy, DDS — San Marcos, Texas, United States
• Premier Research Group Limited — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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