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Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00941304
First received: July 15, 2009
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.

Condition Intervention Phase
Dental Pain
Drug: Oxycodone
Drug: Buprenorphine
Drug: Placebo Film
Drug: Placebo Capsule
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Sum of Pain Intensity Difference From Baseline to 8 Hours [ Time Frame: Baseline, 8 hours ] [ Designated as safety issue: No ]
    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?"


Secondary Outcome Measures:
  • Total Pain Relief Over 8 Hours [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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?"

  • Sum of Pain Relief and Intensity Differences Over 8 Hours [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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?"

  • Sum of Pain Relief and Intensity Differences Over 2 Hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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?"

  • Peak Pain Intensity Difference [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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?"

  • Peak Pain Relief [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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?"

  • Onset of Analgesia [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    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.

  • Duration of Analgesia [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent" [ Time Frame: 8 hours and 24 hours ] [ Designated as safety issue: No ]
    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?"

  • Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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?"

  • Change From Baseline in Cognitive Assessment Using CNS-VS [ Time Frame: Baseline (screening), 2 hours 15 minutes postdose ] [ Designated as safety issue: No ]
    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.


Enrollment: 153
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Opioid
Oxycodone 5-mg oral capsule and 2 buccal placebo films
Drug: Oxycodone
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
Other Name: Oxycodone capsule
Drug: Placebo Film
Single-dose of placebo buccal film
Other Names:
  • Placebo
  • Placebo buccal film
  • BEMA placebo
Experimental: High Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
Drug: Buprenorphine
Single-dose of buprenorphine HCl buccal film
Other Names:
  • BEMA Buprenorphine
  • BELBUCA
  • Buprenorphine HCl buccal film
  • Buprenorphine HCl buccal soluble film
Drug: Placebo Film
Single-dose of placebo buccal film
Other Names:
  • Placebo
  • Placebo buccal film
  • BEMA placebo
Drug: Placebo Capsule
Single-dose of oral placebo capsule
Other Names:
  • Placebo
  • Oxycodone placebo
Experimental: Mid Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Drug: Buprenorphine
Single-dose of buprenorphine HCl buccal film
Other Names:
  • BEMA Buprenorphine
  • BELBUCA
  • Buprenorphine HCl buccal film
  • Buprenorphine HCl buccal soluble film
Drug: Placebo Film
Single-dose of placebo buccal film
Other Names:
  • Placebo
  • Placebo buccal film
  • BEMA placebo
Drug: Placebo Capsule
Single-dose of oral placebo capsule
Other Names:
  • Placebo
  • Oxycodone placebo
Experimental: Low Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
Drug: Buprenorphine
Single-dose of buprenorphine HCl buccal film
Other Names:
  • BEMA Buprenorphine
  • BELBUCA
  • Buprenorphine HCl buccal film
  • Buprenorphine HCl buccal soluble film
Drug: Placebo Film
Single-dose of placebo buccal film
Other Names:
  • Placebo
  • Placebo buccal film
  • BEMA placebo
Drug: Placebo Capsule
Single-dose of oral placebo capsule
Other Names:
  • Placebo
  • Oxycodone placebo
Placebo Comparator: Placebo
Oral placebo capsule and 2 buccal placebo films
Drug: Placebo Film
Single-dose of placebo buccal film
Other Names:
  • Placebo
  • Placebo buccal film
  • BEMA placebo
Drug: Placebo Capsule
Single-dose of oral placebo capsule
Other Names:
  • Placebo
  • Oxycodone placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00941304

Locations
United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
Donald P. Bandy, DDS
San Marcos, Texas, United States, 78666
United States, Utah
Premier Research Group Limited
Salt Lake City, Utah, United States, 84117
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: David Blum, MD BioDelivery Sciences International
  More Information

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00941304     History of Changes
Other Study ID Numbers: BUP-201 
Study First Received: July 15, 2009
Results First Received: November 4, 2015
Last Updated: August 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Buprenorphine
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 26, 2016