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NCT02447848 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
A Phase 3 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 3
- Development phase
- 76
- Enrollment target
NCT02447848: Completed Phase 3 study, sponsored by Talphera.
NCT02447848 is a Phase 3 study that has completed, run by Talphera. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02447848, a Phase 3 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 76 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
Primary Outcome
The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the differen
Interventions
- DRUG sufentanil sublingual 30 mcg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2015-10 |
| Est. Completion | 2016-07 |
| Phase | Phase 3 |
What the finished NCT02447848 record still lists
NCT02447848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which sufentanil sublingual 30 mcg tablet is the first listed.
NCT02447848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02447848 about?
NCT02447848 is a clinical study titled "Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain". To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.
What is the current status of trial NCT02447848?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2015-10. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02447848?
The interventions under investigation include: sufentanil sublingual 30 mcg tablet (DRUG).
Who is sponsoring clinical trial NCT02447848?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02447848's enrollment target sits among peer trials
76 1773rd of 2000 higher than 228 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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