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
Public ClinicalTrials.gov record NCT01539538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01539538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 357 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2012 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Dec 2012 (Actual)
- Last update posted
- Oct 1, 2015
2012
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Eliza Coffee Memorial Hospital | Florence | Alabama | 35630 | — |
| Drug Research and Analysis Corp | Montgomery | Alabama | 36106 | — |
| Shoals Medical Trials, Inc | Sheffield | Alabama | 35660 | — |
| Arizona Research Center | Phoenix | Arizona | 85023 | — |
| Lotus Clinical Research | Pasadena | California | 91105 | — |
| Thorton Hospital | San Diego | California | 92037 | — |
| Florida Research Associates, LLC | DeLand | Florida | 32720 | — |
| River City Clinical Research | Jacksonville | Florida | 32207 | — |
| Pensacola Research Consultants, Inc | Pensacola | Florida | 32504 | — |
| Gulfcoast Research Institute | Sarasota | Florida | 34232 | — |
| Phoenix Clinical Research LLC | Tamarac | Florida | 33321 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Access Clinical Trials | Nashville | Tennessee | 37203 | — |
| Endeavor Clinical Trials, PA | San Antonio | Texas | 78229 | — |
| Jean Brown Research | Salt Lake City | Utah | 84124 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01539538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2015 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01539538 live on ClinicalTrials.gov.