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

A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction

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

Study Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Drug: Oxycodone; Drug: Placebo Film; Drug: Buprenorphine; Drug: Placebo Capsule

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Premier Research Group Limited
    • San Marcos, Texas, United States, 78666
      • Donald P. Bandy, DDS
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Premier Research Group Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Opioid; Oxycodone 5-mg oral capsule and 2 buccal placebo films	Drug: Oxycodone; Single-dose of over-encapsulated oral 5-mg oxycodone capsule; Other Names: Oxycodone capsule; Drug: Placebo Film; Single-dose of placebo buccal film; Other Names: Placebo; Placebo buccal film; BEMA placebo
Experimental: High Dose buprenorphine HCl buccal film; Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule	Drug: Placebo Film; Single-dose of placebo buccal film; Other Names: Placebo; Placebo buccal film; BEMA placebo; Drug: Buprenorphine; Single-dose of buprenorphine HCl buccal film; Other Names: BEMA Buprenorphine; BELBUCA; Buprenorphine HCl buccal film; Buprenorphine HCl buccal soluble film; Drug: Placebo Capsule; Single-dose of oral placebo capsule; Other Names: Placebo; Oxycodone placebo
Experimental: Mid Dose buprenorphine HCl buccal film; Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule	Drug: Placebo Film; Single-dose of placebo buccal film; Other Names: Placebo; Placebo buccal film; BEMA placebo; Drug: Buprenorphine; Single-dose of buprenorphine HCl buccal film; Other Names: BEMA Buprenorphine; BELBUCA; Buprenorphine HCl buccal film; Buprenorphine HCl buccal soluble film; Drug: Placebo Capsule; Single-dose of oral placebo capsule; Other Names: Placebo; Oxycodone placebo
Experimental: Low Dose buprenorphine HCl buccal film; Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule	Drug: Placebo Film; Single-dose of placebo buccal film; Other Names: Placebo; Placebo buccal film; BEMA placebo; Drug: Buprenorphine; Single-dose of buprenorphine HCl buccal film; Other Names: BEMA Buprenorphine; BELBUCA; Buprenorphine HCl buccal film; Buprenorphine HCl buccal soluble film; Drug: Placebo Capsule; Single-dose of oral placebo capsule; Other Names: Placebo; Oxycodone placebo
Placebo Comparator: Placebo; Oral placebo capsule and 2 buccal placebo films	Drug: Placebo Film; Single-dose of placebo buccal film; Other Names: Placebo; Placebo buccal film; BEMA placebo; Drug: Placebo Capsule; Single-dose of oral placebo capsule; Other Names: Placebo; Oxycodone placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Pain Relief Over 8 Hours	Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"	8 hours
Sum of Pain Relief and Intensity Differences Over 8 Hours	Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"	8 hours
Sum of Pain Relief and Intensity Differences Over 2 Hours	Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?" PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"	2 hours
Peak Pain Intensity Difference	The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"	24 hours
Peak Pain Relief	Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to "How much relief have you had from your starting pain?"	24 hours
Onset of Analgesia	Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration.	8 hours
Duration of Analgesia	Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration.	24 hours
Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"	Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication you received for pain?"	8 hours and 24 hours
Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug	Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to "Overall, how would you rate the study medication for this subject?"	24 hours
Change From Baseline in Cognitive Assessment Using CNS-VS	Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that "lower score is better", otherwise higher scores are better.	Baseline (screening), 2 hours 15 minutes postdose

Collaborators and Investigators

• Sponsor: BioDelivery Sciences International
• Investigators: Study Director: David Blum, MD, BioDelivery Sciences International

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 16, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Actual): February 27, 2017
• Last Update Submitted That Met QC Criteria: January 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Oxycodone
• Other Study ID Numbers: BUP-201