Clinical trial NCT01539538: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient Global Satisfaction
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: United States
facility: Eliza Coffee Memorial Hospital
state: Alabama
city: Montgomery
country: United States
facility: Drug Research and Analysis Corp
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials, Inc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: San Diego
country: United States
facility: Thorton Hospital
state: California
city: DeLand
country: United States
facility: Florida Research Associates, LLC
state: Florida
city: Jacksonville
country: United States
facility: River City Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants, Inc
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Tamarac
country: United States
facility: Phoenix Clinical Research LLC
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Access Clinical Trials
state: Tennessee
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, PA
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Talphera, Inc
name: Pamela Palmer, M.D., PhD
role: STUDY_DIRECTOR
References:
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.