Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Opioid | Active Comparator | Oxycodone 5-mg oral capsule and 2 buccal placebo films |
|
| High Dose buprenorphine HCl buccal film | Experimental | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule |
|
| Mid Dose buprenorphine HCl buccal film | Experimental | Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
|
| Low Dose buprenorphine HCl buccal film | Experimental | Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
|
| Placebo | Placebo Comparator | Oral placebo capsule and 2 buccal placebo films |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Single-dose of over-encapsulated oral 5-mg oxycodone capsule |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Blum, MD | BioDelivery Sciences International | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group Limited | Austin | Texas | 78705 | United States | ||
| Donald P. Bandy, DDS |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.25-mg Buprenorphine HCl Buccal Film, M2 | Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule |
| FG001 | 0.5-mg Buprenorphine HCl Buccal Film, M2 | Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule |
| FG002 | 0.5-mg Buprenorphine HCl Buccal Film, M1 | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule |
| FG003 | Placebo | Placebo oral capsule and 2 placebo buccal films |
| FG004 | Oxycodone 5 mg | Oxycodone 5-mg oral capsule and 2 placebo buccal films |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis is based on Safety population; all subjects who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.25-mg Buprenorphine HCl Buccal Film, M2 | Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule |
| BG001 | 0.5-mg Buprenorphine HCl Buccal Film, M2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 hours |
|
From study drug administration (day 1) to follow-up visit (day 6 to 10)
Analysis based on Safety population; all subjects who received any study drug
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.25-mg Buprenorphine HCl Buccal Film, M2 | Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquiries@endo.com |
Not provided
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Buprenorphine | Drug | Single-dose of buprenorphine HCl buccal film |
|
|
| Placebo Film | Drug | Single-dose of placebo buccal film |
|
|
| Placebo Capsule | Drug | Single-dose of oral placebo capsule |
|
|
| 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 |
| San Marcos |
| Texas |
| 78666 |
| United States |
| Premier Research Group Limited | Salt Lake City | Utah | 84117 | United States |
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
| BG002 | 0.5-mg Buprenorphine HCl Buccal Film, M1 | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule |
| BG003 | Placebo | Placebo oral capsule and 2 placebo buccal films |
| BG004 | Oxycodone 5 mg | Oxycodone 5-mg oral capsule and 2 placebo buccal films |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| 0.5-mg Buprenorphine HCl Buccal Film, M2 |
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule |
| OG002 | 0.5-mg Buprenorphine HCl Buccal Film, M1 | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule |
| OG003 | Placebo | Placebo oral capsule and 2 placebo buccal films |
| OG004 | Oxycodone 5 mg | Oxycodone 5-mg oral capsule and 2 placebo buccal films |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | 8 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | 8 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | 2 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Secondary | 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. | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Median | 95% Confidence Interval | hours | 8 hours |
|
|
|
| Secondary | 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. | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Median | 95% Confidence Interval | hours | 24 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Number | percentage of participants | 8 hours and 24 hours |
|
|
|
| Secondary | 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?" | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Number | percentage of participants | 24 hours |
|
|
|
| Secondary | 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. | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Posted | Mean | Standard Deviation | Score | Baseline (screening), 2 hours 15 minutes postdose |
|
|
|
| 0 |
| 31 |
| 9 |
| 31 |
| EG001 | 0.5-mg Buprenorphine HCl Buccal Film, M2 | Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule | 0 | 30 | 18 | 30 |
| EG002 | 0.5-mg Buprenorphine HCl Buccal Film, M1 | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule | 0 | 31 | 25 | 31 |
| EG003 | Placebo | Placebo oral capsule and 2 placebo buccal films | 0 | 30 | 3 | 30 |
| EG004 | Oxycodone 5 mg | Oxycodone 5-mg oral capsule and 2 placebo buccal films | 0 | 31 | 6 | 31 |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Alveolar osteitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
Not provided
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Excellent at 24 hours |
|
| Executive functioning |
|
| Processing speed |
|
| Reaction time |
|