Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
NCT00941304, Phase 2, Completed, BioDelivery Sciences International; results first posted 2016-02-03
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain | ClinicalTrials.gov |
| NCT number | NCT00941304 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 153 participants, actual | ClinicalTrials.gov |
| Lead sponsor | BioDelivery Sciences International | ClinicalTrials.gov |
| Conditions | Dental Pain | ClinicalTrials.gov |
| Interventions | Oxycodone, Buprenorphine, Placebo Film, Placebo Capsule | ClinicalTrials.gov |
| First posted | 2009-07-17 | ClinicalTrials.gov |
| Last updated | 2017-02-27 | ClinicalTrials.gov |
| Results first posted | 2016-02-03 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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?" | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Sum of Pain Intensity Difference From Baseline to 8 Hours | Baseline, 8 hours | Analysis based on intent-to-treat (ITT) population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Total Pain Relief Over 8 Hours | 8 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Sum of Pain Relief and Intensity Differences Over 8 Hours | 8 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Sum of Pain Relief and Intensity Differences Over 2 Hours | 2 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Peak Pain Intensity Difference | 24 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Peak Pain Relief | 24 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Onset of Analgesia | 8 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | hours | MEDIAN | ClinicalTrials.gov |
| SECONDARY | Duration of Analgesia | 24 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | hours | MEDIAN | ClinicalTrials.gov |
| SECONDARY | Percentage of Participants Reporting a Global Rating of Study Drug as Excellent | 8 hours and 24 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | percentage of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Percentage of Participants With Excellent Investigator Global Rating of Study Drug | 24 hours | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | percentage of participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Change From Baseline in Cognitive Assessment Using CNS-VS | Baseline (screening), 2 hours 15 minutes postdose | Analysis based on ITT population; all subjects who received study drug and provided at least 1 post-dose assessment. | Score | MEAN | ClinicalTrials.gov |
Results by group 75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Sum of Pain Intensity Difference From Baseline to 8 Hours | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 6.016 | Standard Deviation 19.9786 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Intensity Difference From Baseline to 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 11.867 | Standard Deviation 20.7418 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Intensity Difference From Baseline to 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 11.282 | Standard Deviation 22.9711 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Intensity Difference From Baseline to 8 Hours | Placebo | 5.283 | Standard Deviation 17.6360 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Intensity Difference From Baseline to 8 Hours | Oxycodone 5 mg | 4.290 | Standard Deviation 14.8645 | units on a scale | ClinicalTrials.gov | |
| Total Pain Relief Over 8 Hours | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 7.274 | Standard Deviation 8.7136 | units on a scale | ClinicalTrials.gov | |
| Total Pain Relief Over 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 9.858 | Standard Deviation 9.3550 | units on a scale | ClinicalTrials.gov | |
| Total Pain Relief Over 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 10.500 | Standard Deviation 9.9358 | units on a scale | ClinicalTrials.gov | |
| Total Pain Relief Over 8 Hours | Placebo | 6.392 | Standard Deviation 8.6235 | units on a scale | ClinicalTrials.gov | |
| Total Pain Relief Over 8 Hours | Oxycodone 5 mg | 6.242 | Standard Deviation 6.6813 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 8 Hours | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 13.290 | Standard Deviation 28.1677 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 21.725 | Standard Deviation 29.7031 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 8 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 21.782 | Standard Deviation 32.2047 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 8 Hours | Placebo | 11.675 | Standard Deviation 25.8038 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 8 Hours | Oxycodone 5 mg | 10.532 | Standard Deviation 20.5848 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 2 Hours | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 0.339 | Standard Deviation 3.4896 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 2 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 1.533 | Standard Deviation 3.5718 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 2 Hours | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 1.056 | Standard Deviation 3.9769 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 2 Hours | Placebo | 0.850 | Standard Deviation 3.5505 | units on a scale | ClinicalTrials.gov | |
| Sum of Pain Relief and Intensity Differences Over 2 Hours | Oxycodone 5 mg | 1.484 | Standard Deviation 3.6009 | units on a scale | ClinicalTrials.gov |
Participant flow 15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 31 | ClinicalTrials.gov | |
| Overall Study | STARTED | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 30 | ClinicalTrials.gov | |
| Overall Study | STARTED | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 31 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 30 | ClinicalTrials.gov | |
| Overall Study | STARTED | Oxycodone 5 mg | 31 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 30 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 30 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 31 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 30 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Oxycodone 5 mg | 31 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 1 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Oxycodone 5 mg | 0 | ClinicalTrials.gov |
Adverse events 30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 6 | 31 | 6 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 14 | 30 | 14 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 20 | 31 | 20 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 30 | 0 | ClinicalTrials.gov |
| other | Nausea | Gastrointestinal disorders | Oxycodone 5 mg | 2 | 31 | 2 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 2 | 31 | 2 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 12 | 30 | 12 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 16 | 31 | 16 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 30 | 0 | ClinicalTrials.gov |
| other | Vomiting | Gastrointestinal disorders | Oxycodone 5 mg | 0 | 31 | 0 | ClinicalTrials.gov |
| other | Alveolar osteitis | Infections and infestations | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 0 | 31 | 0 | ClinicalTrials.gov |
| other | Alveolar osteitis | Infections and infestations | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 2 | 30 | 2 | ClinicalTrials.gov |
| other | Alveolar osteitis | Infections and infestations | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 3 | 31 | 3 | ClinicalTrials.gov |
| other | Alveolar osteitis | Infections and infestations | Placebo | 2 | 30 | 2 | ClinicalTrials.gov |
| other | Alveolar osteitis | Infections and infestations | Oxycodone 5 mg | 2 | 31 | 2 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 5 | 31 | 5 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 6 | 30 | 7 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 13 | 31 | 13 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Placebo | 1 | 30 | 1 | ClinicalTrials.gov |
| other | Dizziness | Nervous system disorders | Oxycodone 5 mg | 0 | 31 | 0 | ClinicalTrials.gov |
Adverse event totals 15
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | 0.25-mg Buprenorphine HCl Buccal Film, M2 | ClinicalTrials.gov | ||
| Total, all-cause mortality | 0.5-mg Buprenorphine HCl Buccal Film, M2 | ClinicalTrials.gov | ||
| Total, all-cause mortality | 0.5-mg Buprenorphine HCl Buccal Film, M1 | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, all-cause mortality | Oxycodone 5 mg | ClinicalTrials.gov | ||
| Total, other adverse events | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 9 | 31 | ClinicalTrials.gov |
| Total, other adverse events | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 18 | 30 | ClinicalTrials.gov |
| Total, other adverse events | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 25 | 31 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 3 | 30 | ClinicalTrials.gov |
| Total, other adverse events | Oxycodone 5 mg | 6 | 31 | ClinicalTrials.gov |
| Total, serious adverse events | 0.25-mg Buprenorphine HCl Buccal Film, M2 | 0 | 31 | ClinicalTrials.gov |
| Total, serious adverse events | 0.5-mg Buprenorphine HCl Buccal Film, M2 | 0 | 30 | ClinicalTrials.gov |
| Total, serious adverse events | 0.5-mg Buprenorphine HCl Buccal Film, M1 | 0 | 31 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 30 | ClinicalTrials.gov |
| Total, serious adverse events | Oxycodone 5 mg | 0 | 31 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)