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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

Primary Purpose

Post-Operative Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sufentanil NanoTab PCA System/15 mcg
morphine IV PCA
Sponsored by
AcelRx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eliza Coffee Memorial Hospital
  • Drug Research and Analysis Corp
  • Shoals Medical Trials, Inc
  • Arizona Research Center
  • Lotus Clinical Research
  • Thorton Hospital
  • Florida Research Associates, LLC
  • River City Clinical Research
  • Pensacola Research Consultants, Inc
  • Gulfcoast Research Institute
  • Phoenix Clinical Research LLC
  • Cleveland Clinic Foundation
  • The Ohio State University
  • Access Clinical Trials
  • Endeavor Clinical Trials, PA
  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sufentanil NanoTab PCA System/15 mcg

morphine IV PCA

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 22, 2012
Last Updated
September 16, 2015
Sponsor
AcelRx Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01539538
Brief 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
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcelRx Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sufentanil NanoTab PCA System/15 mcg
Arm Type
Experimental
Arm Title
morphine IV PCA
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sufentanil NanoTab PCA System/15 mcg
Other Intervention Name(s)
Zalviso™
Intervention Description
15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
Intervention Type
Drug
Intervention Name(s)
morphine IV PCA
Intervention Description
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
Primary Outcome Measure Information:
Title
Patient Global Satisfaction
Description
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Palmer, M.D., PhD
Organizational Affiliation
AcelRx Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Eliza Coffee Memorial Hospital
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Drug Research and Analysis Corp
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
Facility Name
Shoals Medical Trials, Inc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Thorton Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Florida Research Associates, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
River City Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Pensacola Research Consultants, Inc
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Phoenix Clinical Research LLC
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Access Clinical Trials
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25155134
Citation
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.
Results Reference
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Learn more about this trial

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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