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

January 12, 2017 updated by: BioDelivery Sciences International

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sum of Pain Intensity Difference From Baseline to 8 Hours
Time Frame: Baseline, 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Pain Relief Over 8 Hours
Time Frame: 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 Frame: 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 Frame: 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
Time Frame: 24 hours
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
Time Frame: 24 hours
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 Frame: 8 hours
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
Time Frame: 24 hours
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"
Time Frame: 8 hours and 24 hours
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
Time Frame: 24 hours
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
Time Frame: Baseline (screening), 2 hours 15 minutes postdose
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioDelivery Sciences International

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Blum, MD, BioDelivery Sciences International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BUP-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings