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 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 hours and up to 72 hours after surgery while in the hospital.

Study Overview

• Status: Completed
• Conditions: Post-Operative Pain
• Intervention / Treatment: Drug: Sufentanil NanoTab PCA System/15 mcg; Drug: morphine IV PCA

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Florence, Alabama, United States, 35630
      • Eliza Coffee Memorial Hospital
    • Montgomery, Alabama, United States, 36106
      • Drug Research and Analysis Corp
    • Sheffield, Alabama, United States, 35660
      • Shoals Medical Trials, Inc
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research
    • San Diego, California, United States, 92037
      • Thorton Hospital
  • Florida
    • DeLand, Florida, United States, 32720
      • Florida Research Associates, LLC
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
    • Pensacola, Florida, United States, 32504
      • Pensacola Research Consultants, Inc
    • Sarasota, Florida, United States, 34232
      • Gulfcoast Research Institute
    • Tamarac, Florida, United States, 33321
      • Phoenix Clinical Research LLC
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Access Clinical Trials
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sufentanil NanoTab PCA System/15 mcg	Drug: Sufentanil NanoTab PCA System/15 mcg; 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours; Other Names: Zalviso™
ACTIVE_COMPARATOR: morphine IV PCA	Drug: morphine IV PCA; 1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Satisfaction	Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control	48 hours

Collaborators and Investigators

• Sponsor: AcelRx Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Melson TI, Boyer DL, Minkowitz HS, Turan A, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system vs. intravenous patient-controlled analgesia with morphine for postoperative pain control: a randomized, active-comparator trial. Pain Pract. 2014 Nov;14(8):679-88. doi: 10.1111/papr.12238. Epub 2014 Aug 25.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 22, 2012
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (ESTIMATE): February 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 1, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Adult post-operative inpatients who; are expected to require parenteral; opioid analgesia for at least 48; hours after open abdominal surgery; or hip/knee replacement surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Morphine; Sufentanil
• Other Study ID Numbers: IAP309