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
1 other identifier
interventional
357
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 postoperative-pain
Started Apr 2012
Shorter than P25 for phase_3 postoperative-pain
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 27, 2014
CompletedOctober 1, 2015
September 1, 2015
8 months
February 22, 2012
November 25, 2013
September 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Global Satisfaction
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
48 hours
Study Arms (2)
Sufentanil NanoTab PCA System/15 mcg
EXPERIMENTALmorphine IV PCA
ACTIVE COMPARATORInterventions
15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
Eligibility Criteria
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), 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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talphera, Inclead
Study Sites (16)
Eliza Coffee Memorial Hospital
Florence, Alabama, 35630, United States
Drug Research and Analysis Corp
Montgomery, Alabama, 36106, United States
Shoals Medical Trials, Inc
Sheffield, Alabama, 35660, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Lotus Clinical Research
Pasadena, California, 91105, United States
Thorton Hospital
San Diego, California, 92037, United States
Florida Research Associates, LLC
DeLand, Florida, 32720, United States
River City Clinical Research
Jacksonville, Florida, 32207, United States
Pensacola Research Consultants, Inc
Pensacola, Florida, 32504, United States
Gulfcoast Research Institute
Sarasota, Florida, 34232, United States
Phoenix Clinical Research LLC
Tamarac, Florida, 33321, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Access Clinical Trials
Nashville, Tennessee, 37203, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, 78229, United States
Jean Brown Research
Salt Lake City, Utah, 84124, United States
Related Publications (1)
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.
PMID: 25155134BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Palmer
- Organization
- AcelRx
Study Officials
- STUDY DIRECTOR
Pamela Palmer, M.D., PhD
Talphera, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2012
First Posted
February 27, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 1, 2015
Results First Posted
March 27, 2014
Record last verified: 2015-09