At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Fentanyl +3 moredrug
Likely dose
Fentanyl 100 mcgfrom 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.
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial
In Brief
A Phase 3 clinical trial evaluating Fentanyl, Oxycodone/acetaminophen, and 1 other intervention for Pain. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia in comparison to standard analgesia, to determine if the FBT allows for faster achievement of "significant analgesia"
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2011
Enrollment StartMay 2011
Primary CompletionOct 2014
TodayJul 2026
First PostedJan 5, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.5 years ago
Interventions
Fentanyldrug
Fentanyl buccal tablet 100 mcg once
Fentanyldrug
Fentanyl buccal tablet 200 mcg once
Oxycodone/acetaminophendrug
Oxycodone/acetaminophen 5/325 mg once
oxycodone/acetaminophendrug
Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time