Back to resultsStudy of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Buprenorphine
Placebo Film
Placebo Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain
Eligibility Criteria
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
Sites / Locations
- Premier Research Group Limited
- Donald P. Bandy, DDS
- Premier Research Group Limited
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Standard Opioid
High Dose buprenorphine HCl buccal film
Mid Dose buprenorphine HCl buccal film
Low Dose buprenorphine HCl buccal film
Placebo
Arm Description
Oxycodone 5-mg oral capsule and 2 buccal placebo films
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Oral placebo capsule and 2 buccal placebo films
Outcomes
Primary Outcome Measures
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?"
Secondary Outcome Measures
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?"
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?"
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?"
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?"
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?"
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.
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.
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?"
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?"
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.
Full Information
NCT ID
NCT00941304
First Posted
July 15, 2009
Last Updated
January 12, 2017
Sponsor
BioDelivery Sciences International
1. Study Identification
Unique Protocol Identification Number
NCT00941304
Brief Title
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDelivery Sciences International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Opioid
Arm Type
Active Comparator
Arm Description
Oxycodone 5-mg oral capsule and 2 buccal placebo films
Arm Title
High Dose buprenorphine HCl buccal film
Arm Type
Experimental
Arm Description
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Arm Title
Mid Dose buprenorphine HCl buccal film
Arm Type
Experimental
Arm Description
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Arm Title
Low Dose buprenorphine HCl buccal film
Arm Type
Experimental
Arm Description
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo capsule and 2 buccal placebo films
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxycodone capsule
Intervention Description
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
BEMA Buprenorphine, BELBUCA, Buprenorphine HCl buccal film, Buprenorphine HCl buccal soluble film
Intervention Description
Single-dose of buprenorphine HCl buccal film
Intervention Type
Drug
Intervention Name(s)
Placebo Film
Other Intervention Name(s)
Placebo, Placebo buccal film, BEMA placebo
Intervention Description
Single-dose of placebo buccal film
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Other Intervention Name(s)
Placebo, Oxycodone placebo
Intervention Description
Single-dose of oral placebo capsule
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Difference From Baseline to 8 Hours
Description
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?"
Time Frame
Baseline, 8 hours
Secondary Outcome Measure Information:
Title
Total Pain Relief Over 8 Hours
Description
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?"
Time Frame
8 hours
Title
Sum of Pain Relief and Intensity Differences Over 8 Hours
Description
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?"
Time Frame
8 hours
Title
Sum of Pain Relief and Intensity Differences Over 2 Hours
Description
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?"
Time Frame
2 hours
Title
Peak Pain Intensity Difference
Description
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?"
Time Frame
24 hours
Title
Peak Pain Relief
Description
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?"
Time Frame
24 hours
Title
Onset of Analgesia
Description
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.
Time Frame
8 hours
Title
Duration of Analgesia
Description
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.
Time Frame
24 hours
Title
Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"
Description
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?"
Time Frame
8 hours and 24 hours
Title
Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug
Description
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?"
Time Frame
24 hours
Title
Change From Baseline in Cognitive Assessment Using CNS-VS
Description
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.
Time Frame
Baseline (screening), 2 hours 15 minutes postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Blum, MD
Organizational Affiliation
BioDelivery Sciences International
Official's Role
Study Director
Facility Information:
Facility Name
Premier Research Group Limited
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Donald P. Bandy, DDS
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Premier Research Group Limited
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
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