At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
Oxycodone +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Oxycodone, Buprenorphine, and 2 other interventions for Dental Pain. Completed, enrolled 153 participants across 3 sites.
Detailed Summary
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionNov 2009
TodayJul 2026
First PostedJul 17, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.0 years ago
Interventions
Oxycodonedrug
Single-dose of over-encapsulated oral 5-mg oxycodone capsule
Buprenorphinedrug
Single-dose of buprenorphine HCl buccal film
Placebo Filmdrug
Single-dose of placebo buccal film
Placebo Capsuledrug
Single-dose of oral placebo capsule