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NCT01539642 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
A Phase 3 study, sponsored by Talphera.
- Completed
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
NCT01539642: Completed Phase 3 study, sponsored by Talphera.
NCT01539642 is a Phase 3 study that has completed, run by Talphera. The registered enrollment target is 172 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539642, a Phase 3 study, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.
Primary Outcome
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.
Interventions
- DRUG Sufentanil NanoTab PCA System/15 mcg
- DRUG Placebo Sufentanil NanoTab PCA System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01539642 record still lists
NCT01539642 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.
NCT01539642 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01539642 about?
NCT01539642 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery". The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.
What is the current status of trial NCT01539642?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2012-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01539642?
The interventions under investigation include: Sufentanil NanoTab PCA System/15 mcg (DRUG), Placebo Sufentanil NanoTab PCA System (DRUG).
Who is sponsoring clinical trial NCT01539642?
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 NCT01539642's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 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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