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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post-Operative Pain

In brief

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.

Key facts

Study ID

NCT01539642

Run by

Talphera, Inc

People needed

172

Starts

2012-02-01

Expected to finish

2013-02-01

Last updated by the study team

2015-10-20

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) 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

• Surgical Associates of Mobile — Mobile, Alabama, United States
• Caring Clinical Research Corporation — Laguna Hills, California, United States
• The Stamford Hospital — Stamford, Connecticut, United States
• G&G Research — Vero Beach, Florida, United States
• Rush Pain Center — Chicago, Illinois, United States
• CRC of Jackson — Jackson, Mississippi, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Phoenix OB GYN Associates — Moorestown, New Jersey, United States
• New York Methodist Hospital — Brooklyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Jefferson Hospital — Philadelphia, Pennsylvania, United States
• Memorial Hermann -Memorial City Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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