Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00941304
Other study ID # BUP-201
Secondary ID
Status Completed
Phase Phase 2
First received July 15, 2009
Last updated January 4, 2016
Start date August 2009
Est. completion date November 2009

Study information

Verified date January 2016
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 153
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oxycodone
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
Buprenorphine
Single-dose of buprenorphine HCl buccal film
Placebo Film
Single-dose of placebo buccal film
Placebo Capsule
Single-dose of oral placebo capsule

Locations

Country Name City State
United States Premier Research Group Limited Austin Texas
United States Premier Research Group Limited Salt Lake City Utah
United States Donald P. Bandy, DDS San Marcos Texas

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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?" Baseline, 8 hours No
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?" 8 hours No
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?" 8 hours No
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?" 2 hours No
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?" 24 hours No
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?" 24 hours No
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. 8 hours No
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. 24 hours No
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?" 8 hours and 24 hours No
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?" 24 hours No
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. Baseline (screening), 2 hours 15 minutes postdose No
See also
  Status Clinical Trial Phase
Completed NCT00942448 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery Phase 3
Completed NCT00943098 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery Phase 3
Completed NCT00985439 - Study of Diclofenac Capsules to Treat Dental Pain Phase 2
Completed NCT00954356 - Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction Phase 2
Completed NCT02966067 - A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery N/A
Completed NCT01960114 - Study of Long-Acting Acetaminophen in Postoperative Dental Pain Phase 2
Completed NCT01229228 - Study of Naproxen Capsules to Treat Dental Pain Phase 2
Completed NCT01177423 - Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block N/A
Completed NCT03328208 - Nonpharmacologic Reduction of Periprocedural Distress and Drug Use N/A
Completed NCT05236101 - Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety N/A
Completed NCT00542035 - A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction Phase 2
Completed NCT04231955 - Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth N/A
Completed NCT02096926 - Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery Phase 4
Completed NCT05369936 - Pain Perception: on Relationships Between Dental Anxiety and Olfaction N/A
Recruiting NCT05351099 - Dental Block for Pain Relief in ED Dental Pain Patients
Not yet recruiting NCT06269406 - A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults N/A
Recruiting NCT05443009 - Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction Phase 4
Terminated NCT02161354 - Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars Phase 2
Completed NCT04949126 - Self Medication in Odontology (AUDE)
Completed NCT03652818 - Dental Pain Study of Analgesics in Patients Undergoing Molar Removal Phase 2