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NCT01539538 · ClinicalTrials.gov registry record · Phase 3
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
A Phase 3 study of Postoperative Pain, sponsored by Talphera.
- Completed
- Registry status
- Phase 3
- Development phase
- 357
- Enrollment target
- 16
- Study locations
NCT01539538: Completed Phase 3 study of Postoperative Pain, sponsored by Talphera.
NCT01539538 is a Phase 3 study of Postoperative Pain that has completed, run by Talphera. The registered enrollment target is 357 participants, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (56% higher). The trial reports 16 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539538, a Phase 3 study of Postoperative Pain, has completed, sponsored by Talphera.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 357 participants
- Enrollment target
- 16
- Study locations
Study Summary
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
Primary Outcome
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Conditions Studied
Interventions
- DRUG Sufentanil NanoTab PCA System/15 mcg
- DRUG morphine IV PCA
Study Locations (16)
Florida
- Florida Research Associates, LLC - DeLand
- River City Clinical Research - Jacksonville
- Pensacola Research Consultants, Inc - Pensacola
- Gulfcoast Research Institute - Sarasota
- Phoenix Clinical Research LLC - Tamarac
Alabama
- Eliza Coffee Memorial Hospital - Florence
- Drug Research and Analysis Corp - Montgomery
- Shoals Medical Trials, Inc - Sheffield
California
- Lotus Clinical Research - Pasadena
- Thorton Hospital - San Diego
Ohio
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
Arizona
- Arizona Research Center - Phoenix
Tennessee
- Access Clinical Trials - Nashville
Texas
- Endeavor Clinical Trials, PA - San Antonio
Utah
- Jean Brown Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT01539538 record still lists
NCT01539538 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 229-participant average among 120 other Postoperative Pain trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Sufentanil NanoTab PCA System/15 mcg is the first listed.
NCT01539538 lists 16 locations in 8 states (Florida, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT01539538 about?
NCT01539538 is a clinical study titled "A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain". The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 ho...
What is the current status of trial NCT01539538?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 357 participants. The study started on 2012-04. Estimated completion is 2012-12.
What conditions does trial NCT01539538 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT01539538?
The interventions under investigation include: Sufentanil NanoTab PCA System/15 mcg (DRUG), morphine IV PCA (DRUG).
Who is sponsoring clinical trial NCT01539538?
This trial is sponsored by Talphera, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01539538 being conducted?
This trial has 16 study locations across Alabama, Arizona, California, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01539538's enrollment target sits among peer trials
357 14th of 120 higher than 107 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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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