Dental PainPhase 2NCT00941304
Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain
A Phase 2 study testing Oxycodone and Buprenorphine in people with Dental Pain, run by BioDelivery Sciences International at 3 sites in United States.
Trial summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dental Pain
- What is being tested?
- Oxycodone and Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Premier Research Group Limited
Austin, Texas, 78705
Premier Research Group Limited
Salt Lake City, Utah, 84117
Donald P. Bandy, DDS
San Marcos, Texas, 78666
About this study
Official title: A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
- Conditions
- Dental Pain
- Being tested
- Oxycodone, Buprenorphine, Placebo Film, Placebo Capsule
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxycodone capsule
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
BuprenorphineDrug
Also called BEMA Buprenorphine, BELBUCA, Buprenorphine HCl buccal film, Buprenorphine HCl buccal soluble film
Single-dose of buprenorphine HCl buccal film
Placebo FilmDrug
Also called Placebo, Placebo buccal film, BEMA placebo
Single-dose of placebo buccal film
Placebo CapsuleDrug
Also called Placebo, Oxycodone placebo
Single-dose of oral placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Standard Opioid | Active comparator | Oxycodone 5-mg oral capsule and 2 buccal placebo films Receives: Drug: Oxycodone; Drug: Placebo Film |
| High Dose buprenorphine HCl buccal film | Experimental | Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule Receives: Drug: Buprenorphine; Drug: Placebo Film; Drug: 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 Receives: Drug: Buprenorphine; Drug: Placebo Film; Drug: 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 Receives: Drug: Buprenorphine; Drug: Placebo Film; Drug: Placebo Capsule |
| Placebo | Placebo comparator | Oral placebo capsule and 2 buccal placebo films Receives: Drug: Placebo Film; Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: Baseline, 8 hours
Secondary outcomes (10)
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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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?"
Measured: 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.
Measured: 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.
Measured: 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?"
Measured: 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?"
Measured: 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.
Measured: Baseline (screening), 2 hours 15 minutes postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Blum, MD, Study director, BioDelivery Sciences International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941304
- Sponsor's protocol ID
- BUP-201
- Status last verified
- Jan 2017
- First submitted
- 15 Jul 2009
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction
- ClinicalTrials.gov ID
- NCT00941304
- Acronym / sponsor ID
- BUP-201
- Conditions
- Dental Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- BioDelivery Sciences InternationalIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 Jul 2009 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard Opioid | Active comparator | Drug: Oxycodone, Drug: Placebo FilmOxycodone 5-mg oral capsule and 2 buccal placebo films |
| High Dose buprenorphine HCl buccal film | Experimental | Drug: Buprenorphine, Drug: Placebo Film, Drug: Placebo CapsuleBuprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule |
| Mid Dose buprenorphine HCl buccal film | Experimental | Drug: Buprenorphine, Drug: Placebo Film, Drug: Placebo CapsuleBuprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
| Low Dose buprenorphine HCl buccal film | Experimental | Drug: Buprenorphine, Drug: Placebo Film, Drug: Placebo CapsuleBuprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule |
| Placebo | Placebo comparator | Drug: Placebo Film, Drug: Placebo CapsuleOral placebo capsule and 2 buccal placebo films |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneAlso: Oxycodone capsuleSingle-dose of over-encapsulated oral 5-mg oxycodone capsule | Drug | Standard Opioid |
| BuprenorphineAlso: BEMA Buprenorphine, BELBUCA, Buprenorphine HCl buccal film, Buprenorphine HCl buccal soluble filmSingle-dose of buprenorphine HCl buccal film | Drug | High Dose buprenorphine HCl buccal film, Low Dose buprenorphine HCl buccal film, Mid Dose buprenorphine HCl buccal film |
| Placebo FilmAlso: Placebo, Placebo buccal film, BEMA placeboSingle-dose of placebo buccal film | Drug | High Dose buprenorphine HCl buccal film, Low Dose buprenorphine HCl buccal film, Mid Dose buprenorphine HCl buccal film, Placebo, Standard Opioid |
| Placebo CapsuleAlso: Placebo, Oxycodone placeboSingle-dose of oral placebo capsule | Drug | High Dose buprenorphine HCl buccal film, Low Dose buprenorphine HCl buccal film, Mid Dose buprenorphine HCl buccal film, Placebo |
Primary outcome
Sum of Pain Intensity Difference From Baseline to 8 Hours
Time frame: 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?"
10 secondary outcomes
Total Pain Relief Over 8 Hours
Time frame: 8 hours
Sum of Pain Relief and Intensity Differences Over 8 Hours
Time frame: 8 hours
Sum of Pain Relief and Intensity Differences Over 2 Hours
Time frame: 2 hours
Peak Pain Intensity Difference
Time frame: 24 hours
Peak Pain Relief
Time frame: 24 hours
Onset of Analgesia
Time frame: 8 hours
Duration of Analgesia
Time frame: 24 hours
Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"
Time frame: 8 hours and 24 hours
Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug
Time frame: 24 hours
Change From Baseline in Cognitive Assessment Using CNS-VS
Time frame: Baseline (screening), 2 hours 15 minutes postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Blum, MD study director
BioDelivery Sciences International
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxycodone and Buprenorphine in people with Dental Pain, run by BioDelivery Sciences International at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Pain Intensity Difference From Baseline to 8 Hours (time frame: Baseline, 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.