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
NCT ID: NCT01539538
Last Updated: 2015-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
357 participants
INTERVENTIONAL
2012-04-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sufentanil NanoTab PCA System/15 mcg
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
morphine IV PCA
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 with an allergy or hypersensitivity to opioids
* Female patients who are pregnant or breast-feeding
18 Years
ALL
No
Sponsors
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Talphera, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela Palmer, M.D., PhD
Role: STUDY_DIRECTOR
Talphera, Inc
Locations
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Eliza Coffee Memorial Hospital
Florence, Alabama, United States
Drug Research and Analysis Corp
Montgomery, Alabama, United States
Shoals Medical Trials, Inc
Sheffield, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Lotus Clinical Research
Pasadena, California, United States
Thorton Hospital
San Diego, California, United States
Florida Research Associates, LLC
DeLand, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Pensacola Research Consultants, Inc
Pensacola, Florida, United States
Gulfcoast Research Institute
Sarasota, Florida, United States
Phoenix Clinical Research LLC
Tamarac, Florida, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Access Clinical Trials
Nashville, Tennessee, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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References
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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.
Other Identifiers
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IAP309
Identifier Type: -
Identifier Source: org_study_id
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