A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
NCT ID: NCT01539642
Last Updated: 2015-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
172 participants
INTERVENTIONAL
2012-02-29
2013-02-28
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
QUADRUPLE
Study Groups
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Sufentanil NanoTab PCA System/15 mcg
Sufentanil NanoTab PCA System/15 mcg
15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Placebo Sufentanil NanoTab PCA System
Placebo Sufentanil NanoTab PCA System
Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Interventions
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Sufentanil NanoTab PCA System/15 mcg
15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
Placebo Sufentanil NanoTab PCA System
Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for 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) 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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Surgical Associates of Mobile
Mobile, Alabama, United States
Caring Clinical Research Corporation
Laguna Hills, California, United States
The Stamford Hospital
Stamford, Connecticut, United States
G&G Research
Vero Beach, Florida, United States
Rush Pain Center
Chicago, Illinois, United States
CRC of Jackson
Jackson, Mississippi, United States
Cooper University Hospital
Camden, New Jersey, United States
Phoenix OB GYN Associates
Moorestown, New Jersey, United States
New York Methodist Hospital
Brooklyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Jefferson Hospital
Philadelphia, Pennsylvania, United States
Memorial Hermann -Memorial City Medical Center
Houston, Texas, United States
Countries
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References
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Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152.
Other Identifiers
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IAP310
Identifier Type: -
Identifier Source: org_study_id
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