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

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Buprenorphine; Drug: Oxycodone; Drug: Placebo Film; Drug: Placebo Capsule

• Registration Number: NCT00941304
• Lead Sponsor: BioDelivery Sciences International

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-15
• Study First Submitted QC: 2009-07-16
• Study First Posted: 2009-07-17
• Study Start: 2009-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Disposition First Submitted: 2015-02-24
• Disposition First Submitted QC: 2015-02-24
• Disposition First Posted: 2015-03-17
• Results First Submitted: 2015-11-04
• Results First Submitted QC: 2016-01-04
• Results First Posted: 2016-02-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Opioid	Placebo Film	Oxycodone 5-mg oral capsule and 2 buccal placebo films
High Dose buprenorphine HCl buccal film	Placebo Capsule	Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Mid Dose buprenorphine HCl buccal film	Placebo Film	Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Placebo	Placebo Capsule	Oral placebo capsule and 2 buccal placebo films
High Dose buprenorphine HCl buccal film	Placebo Film	Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Mid Dose buprenorphine HCl buccal film	Placebo Capsule	Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Low Dose buprenorphine HCl buccal film	Buprenorphine	Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Low Dose buprenorphine HCl buccal film	Placebo Film	Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Low Dose buprenorphine HCl buccal film	Placebo Capsule	Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Placebo	Placebo Film	Oral placebo capsule and 2 buccal placebo films
Standard Opioid	Oxycodone	Oxycodone 5-mg oral capsule and 2 buccal placebo films
High Dose buprenorphine HCl buccal film	Buprenorphine	Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Mid Dose buprenorphine HCl buccal film	Buprenorphine	Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference From Baseline to 8 Hours	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?"

Secondary Outcome Measures

Name	Time	Method
Sum of Pain Relief and Intensity Differences Over 8 Hours	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	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	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?"
Peak Pain Relief	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?"
Onset of Analgesia	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.
Duration of Analgesia	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.
Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"	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?"
Total Pain Relief Over 8 Hours	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?"
Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug	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?"
Change From Baseline in Cognitive Assessment Using CNS-VS	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.

Trial Locations

Locations (2)

Donald P. Bandy, DDS; 🇺🇸 San Marcos, Texas, United States

Premier Research Group Limited; 🇺🇸 Salt Lake City, Utah, United States