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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Page 1 of 1 (3 locations)

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