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

NCT00941304 | Completed Phase 2 Results

• 1 other identifier: BUP-201
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference From Baseline to 8 Hours

  Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"

  Baseline, 8 hours

Secondary Outcomes (10)

• Total Pain Relief Over 8 Hours

  8 hours

• Sum of Pain Relief and Intensity Differences Over 8 Hours

  8 hours

• Sum of Pain Relief and Intensity Differences Over 2 Hours

  2 hours

• Peak Pain Intensity Difference

  24 hours

• Peak Pain Relief

  24 hours

Study Arms (5)

Standard Opioid

ACTIVE COMPARATOR

Oxycodone 5-mg oral capsule and 2 buccal placebo films

Drug: Oxycodone; Drug: Placebo Film

High Dose buprenorphine HCl buccal film

EXPERIMENTAL

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

Drug: Buprenorphine; Drug: Placebo Film; Drug: Placebo Capsule

Mid Dose buprenorphine HCl buccal film

EXPERIMENTAL

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

Drug: Buprenorphine; Drug: Placebo Film; Drug: Placebo Capsule

Low Dose buprenorphine HCl buccal film

EXPERIMENTAL

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

Drug: Buprenorphine; Drug: Placebo Film; Drug: Placebo Capsule

Placebo

PLACEBO COMPARATOR

Oral placebo capsule and 2 buccal placebo films

Drug: Placebo Film; Drug: Placebo Capsule

Interventions

Oxycodone DRUG

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

Also known as: Oxycodone capsule

Standard Opioid

Buprenorphine DRUG

Single-dose of buprenorphine HCl buccal film

Also known as: BEMA Buprenorphine, BELBUCA, Buprenorphine HCl buccal film, Buprenorphine HCl buccal soluble film

High Dose buprenorphine HCl buccal film; Low Dose buprenorphine HCl buccal film; Mid Dose buprenorphine HCl buccal film

Placebo Film DRUG

Single-dose of placebo buccal film

Also known as: Placebo, Placebo buccal film, BEMA placebo

High Dose buprenorphine HCl buccal film; Low Dose buprenorphine HCl buccal film; Mid Dose buprenorphine HCl buccal film; Placebo; Standard Opioid

Placebo Capsule DRUG

Single-dose of oral placebo capsule

Also known as: Placebo, Oxycodone placebo

High Dose buprenorphine HCl buccal film; Low Dose buprenorphine HCl buccal film; Mid Dose buprenorphine HCl buccal film; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• BioDelivery Sciences International: lead

Study Sites (3)

Premier Research Group Limited

Austin, Texas, 78705, United States

Location

Donald P. Bandy, DDS

San Marcos, Texas, 78666, United States

Location

Premier Research Group Limited

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Toothache

Interventions

Oxycodone; Buprenorphine

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals Inc.

clinicalsite.inquiries@endo.com

Study Officials

• David Blum, MD

  BioDelivery Sciences International

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 27, 2017
• Results First Posted: February 3, 2016

Record last verified: 2017-01

Locations

US (3)