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

BioDelivery Sciences International

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Oxycodone; Drug: Buprenorphine; Drug: Placebo Capsule; Drug: Placebo Film

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941304

BUP-201

Details and patient eligibility

About

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

Enrollment: 153 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 5 patient groups, including a placebo group

Standard Opioid

Active Comparator group

Description:

Oxycodone 5-mg oral capsule and 2 buccal placebo films

Treatment:

Drug: Placebo Film

Drug: Oxycodone

High Dose buprenorphine HCl buccal film

Experimental group

Description:

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

Treatment:

Drug: Placebo Film

Drug: Placebo Capsule

Drug: Buprenorphine

Mid Dose buprenorphine HCl buccal film

Experimental group

Description:

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

Treatment:

Drug: Placebo Film

Drug: Placebo Capsule

Drug: Buprenorphine

Low Dose buprenorphine HCl buccal film

Experimental group

Description:

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

Treatment:

Drug: Placebo Film

Drug: Placebo Capsule

Drug: Buprenorphine

Placebo

Placebo Comparator group

Description:

Oral placebo capsule and 2 buccal placebo films

Treatment:

Drug: Placebo Film

Drug: Placebo Capsule