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NCT01710345 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
A Phase 2 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT01710345: Completed Phase 2 study, sponsored by Talphera.
NCT01710345 is a Phase 2 study that has completed, run by Talphera. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01710345, a Phase 2 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
Primary Outcome
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-1
Interventions
- DRUG Placebo NanoTab
- DRUG Sufentanil NanoTab 20 mcg
- DRUG Sufentanil NanoTab 30 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
What the finished NCT01710345 record still lists
NCT01710345 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo NanoTab is the first listed.
NCT01710345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01710345 about?
NCT01710345 is a clinical study titled "Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy". This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
What is the current status of trial NCT01710345?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2012-10. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01710345?
The interventions under investigation include: Placebo NanoTab (DRUG), Sufentanil NanoTab 20 mcg (DRUG), Sufentanil NanoTab 30 mcg (DRUG).
Who is sponsoring clinical trial NCT01710345?
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 NCT01710345's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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