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

Phase 3

Completed

• Conditions: Post-Operative Pain
• Interventions: Drug: morphine IV PCA; Drug: Sufentanil NanoTab PCA System/15 mcg

• Registration Number: NCT01539538
• Lead Sponsor: Talphera, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-22
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Study Start: 2012-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-11-25
• Results First Submitted QC: 2014-02-10
• Results First Posted: 2014-03-27
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-16
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morphine IV PCA	morphine IV PCA	-
Sufentanil NanoTab PCA System/15 mcg	Sufentanil NanoTab PCA System/15 mcg	-

Primary Outcome Measures

Name	Time	Method
Patient Global Satisfaction	48 hours	Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control

Trial Locations

Locations (16)

Shoals Medical Trials, Inc; 🇺🇸 Sheffield, Alabama, United States

Florida Research Associates, LLC; 🇺🇸 DeLand, Florida, United States

Pensacola Research Consultants, Inc; 🇺🇸 Pensacola, Florida, United States

Phoenix Clinical Research LLC; 🇺🇸 Tamarac, Florida, United States

Eliza Coffee Memorial Hospital; 🇺🇸 Florence, Alabama, United States

Lotus Clinical Research; 🇺🇸 Pasadena, California, United States

River City Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Thorton Hospital; 🇺🇸 San Diego, California, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Endeavor Clinical Trials, PA; 🇺🇸 San Antonio, Texas, United States

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States

Drug Research and Analysis Corp; 🇺🇸 Montgomery, Alabama, United States

Arizona Research Center; 🇺🇸 Phoenix, Arizona, United States

Gulfcoast Research Institute; 🇺🇸 Sarasota, Florida, United States

Access Clinical Trials; 🇺🇸 Nashville, Tennessee, United States