Status:
COMPLETED
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Lead Sponsor:
BioDelivery Sciences International
Conditions:
Dental Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00941304
Start Date
August 1 2009
End Date
November 1 2009
Last Update
February 27 2017
Active Locations (3)
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1
Premier Research Group Limited
Austin, Texas, United States, 78705
2
Donald P. Bandy, DDS
San Marcos, Texas, United States, 78666
3
Premier Research Group Limited
Salt Lake City, Utah, United States, 84117