The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
153
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
Single-dose of buprenorphine HCl buccal film
Single-dose of placebo buccal film
Premier Research Group Limited
Austin, Texas, United States
Donald P. Bandy, DDS
San Marcos, Texas, United States
Premier Research Group Limited
Salt Lake City, Utah, United States
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?"
Time frame: Baseline, 8 hours
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?"
Time frame: 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?"
Time frame: 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?"
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single-dose of oral placebo capsule
Time frame: 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?"
Time frame: 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?"
Time frame: 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.
Time frame: 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.
Time frame: 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?"
Time frame: 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?"
Time frame: 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.
Time frame: Baseline (screening), 2 hours 15 minutes postdose