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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Opioid

Oxycodone 5-mg oral capsule and 2 buccal placebo films

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Single-dose of over-encapsulated oral 5-mg oxycodone capsule

Placebo Film

Intervention Type DRUG

Single-dose of placebo buccal film

High Dose buprenorphine HCl buccal film

Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Single-dose of buprenorphine HCl buccal film

Placebo Film

Intervention Type DRUG

Single-dose of placebo buccal film

Placebo Capsule

Intervention Type DRUG

Single-dose of oral placebo capsule

Mid Dose buprenorphine HCl buccal film

Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Single-dose of buprenorphine HCl buccal film

Placebo Film

Intervention Type DRUG

Single-dose of placebo buccal film

Placebo Capsule

Intervention Type DRUG

Single-dose of oral placebo capsule

Low Dose buprenorphine HCl buccal film

Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Single-dose of buprenorphine HCl buccal film

Placebo Film

Intervention Type DRUG

Single-dose of placebo buccal film

Placebo Capsule

Intervention Type DRUG

Single-dose of oral placebo capsule

Placebo

Oral placebo capsule and 2 buccal placebo films

Group Type PLACEBO_COMPARATOR

Placebo Film

Intervention Type DRUG

Single-dose of placebo buccal film

Placebo Capsule

Intervention Type DRUG

Single-dose of oral placebo capsule

Interventions

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Oxycodone

Single-dose of over-encapsulated oral 5-mg oxycodone capsule

Intervention Type DRUG

Buprenorphine

Single-dose of buprenorphine HCl buccal film

Intervention Type DRUG

Placebo Film

Single-dose of placebo buccal film

Intervention Type DRUG

Placebo Capsule

Single-dose of oral placebo capsule

Intervention Type DRUG

Other Intervention Names

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Oxycodone capsule BEMA Buprenorphine BELBUCA Buprenorphine HCl buccal film Buprenorphine HCl buccal soluble film Placebo Placebo buccal film BEMA placebo Placebo Oxycodone placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No