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

Dental Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941304
• Other study ID #: BUP-201
• 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

• Dental Pain
• Toothache

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