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NCT01270659 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
A Phase 3 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT01270659: Completed Phase 3 study, sponsored by University of Oklahoma.
NCT01270659 is a Phase 3 study that has completed, run by University of Oklahoma. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01270659, a Phase 3 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study 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"
Primary Outcome
Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever).
Interventions
- DRUG Fentanyl
- DRUG Oxycodone/acetaminophen
- DRUG oxycodone/acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-05 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT01270659 record still lists
NCT01270659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Fentanyl is the first listed.
NCT01270659 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01270659 about?
NCT01270659 is a clinical study titled "Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury". 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"
What is the current status of trial NCT01270659?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2011-05. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01270659?
The interventions under investigation include: Fentanyl (DRUG), Oxycodone/acetaminophen (DRUG), oxycodone/acetaminophen (DRUG).
Who is sponsoring clinical trial NCT01270659?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01270659's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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