Phase 2
N=153
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
Dental Pain
Bottom Line
View on ClinicalTrials.gov: NCT00941304 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Sum of Pain Intensity Difference From Baseline to 8 Hours — 6.016; 11.867; 11.282; 5.283 units on a scale — p=.4739
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxycodone (Drug); Buprenorphine (Drug); Placebo Film (Drug); Placebo Capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioDelivery Sciences International
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference From Baseline to 8 Hours |
6.016; 11.867; 11.282; 5.283; 4.290 | .4739 |
| SECONDARY Total Pain Relief Over 8 Hours |
7.274; 9.858; 10.500; 6.392; 6.242 | — |
| SECONDARY Sum of Pain Relief and Intensity Differences Over 8 Hours |
13.290; 21.725; 21.782; 11.675; 10.532 | — |
| SECONDARY Sum of Pain Relief and Intensity Differences Over 2 Hours |
0.339; 1.533; 1.056; 0.850; 1.484 | — |
| SECONDARY Peak Pain Intensity Difference |
2.2; 2.9; 2.8; 1.5; 1.9 | — |
| SECONDARY Peak Pain Relief |
1.5; 1.8; 1.9; 1.1; 1.3 | — |
| SECONDARY Onset of Analgesia |
NA; 2.43; NA; NA; NA | — |
| SECONDARY Duration of Analgesia |
1.75; 2.62; 4.12; 1.69; 2.17 | — |
| SECONDARY Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent" |
3.2; 6.7; 9.7; 6.7; 3.2; 9.7 | — |
| SECONDARY Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug |
6.5; 13.3; 12.9; 3.3; 0 | — |
| SECONDARY Change From Baseline in Cognitive Assessment Using CNS-VS |
5.9; 4.0; -3.2; 7.3; 2.1; 5.7 | — |
Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of 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
Data sourced from ClinicalTrials.gov (NCT00941304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.