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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 is a Phase 3 study that has completed, run by Talphera. The registered enrollment target is 172 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01539642
The ClinicalTrials.gov registry entry for NCT01539642 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Talphera, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.
NCT01539642 reports 0 study locations.
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.
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