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NCT02356588 · ClinicalTrials.gov registry record · Phase 3
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
A Phase 3 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 3
- Development phase
- 161
- Enrollment target
NCT02356588: Completed Phase 3 study, sponsored by Talphera.
NCT02356588 is a Phase 3 study that has completed, run by Talphera. The registered enrollment target is 161 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356588, a Phase 3 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 161 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
Primary Outcome
The primary outcome measure is the summed pain intensity difference to baseline 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 observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo
Interventions
- DRUG Placebo Tablet
- DRUG Sufentanil Tablet 30 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT02356588 record still lists
NCT02356588 is an interventional study that assigns participants to a tested intervention. The registered 161 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Tablet is the first listed.
NCT02356588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02356588 about?
NCT02356588 is a clinical study titled "A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery". The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
What is the current status of trial NCT02356588?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 161 participants. The study started on 2015-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02356588?
The interventions under investigation include: Placebo Tablet (DRUG), Sufentanil Tablet 30 mcg (DRUG).
Who is sponsoring clinical trial NCT02356588?
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 NCT02356588's enrollment target sits among peer trials
161 1478th of 2000 higher than 522 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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