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

Completed · Phase 3

Conditions studied: Post-Operative Pain

In brief

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.

Key facts

Study ID

NCT01539538

Run by

Talphera, Inc

People needed

357

Starts

2012-04-01

Expected to finish

2012-12-01

Last updated by the study team

2015-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients who are 18 years or older
• Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
• Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.

You may not qualify if…

• Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
• Patients with an allergy or hypersensitivity to opioids
• Female patients who are pregnant or breast-feeding

Where it is running

• Eliza Coffee Memorial Hospital — Florence, Alabama, United States
• Drug Research and Analysis Corp — Montgomery, Alabama, United States
• Shoals Medical Trials, Inc — Sheffield, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Lotus Clinical Research — Pasadena, California, United States
• Thorton Hospital — San Diego, California, United States
• Florida Research Associates, LLC — DeLand, Florida, United States
• River City Clinical Research — Jacksonville, Florida, United States
• Pensacola Research Consultants, Inc — Pensacola, Florida, United States
• Gulfcoast Research Institute — Sarasota, Florida, United States
• Phoenix Clinical Research LLC — Tamarac, Florida, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Access Clinical Trials — Nashville, Tennessee, United States
• Endeavor Clinical Trials, PA — San Antonio, Texas, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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