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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

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ClinicalTrials.gov Identifier: NCT01539538
Recruitment Status : Completed
First Posted : February 27, 2012
Results First Posted : March 27, 2014
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Drug: Sufentanil NanoTab PCA System/15 mcg Drug: morphine IV PCA Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Patient Global Satisfaction [ Time Frame: 48 hours ]
    Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539538


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

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Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01539538    
Other Study ID Numbers: IAP309
First Posted: February 27, 2012    Key Record Dates
Results First Posted: March 27, 2014
Last Update Posted: October 1, 2015
Last Verified: September 2015
Keywords provided by AcelRx Pharmaceuticals, Inc.:
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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Sufentanil
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics