Clinical trial NCT01539642: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Operative Pain
Keywords: In patient, post operative pain
Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 172
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 purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.


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) 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: Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Surgical Associates of Mobile
state: Alabama
city: Laguna Hills
country: United States
facility: Caring Clinical Research Corporation
state: California
city: Stamford
country: United States
facility: The Stamford Hospital
state: Connecticut
city: Vero Beach
country: United States
facility: G&G Research
state: Florida
city: Chicago
country: United States
facility: Rush Pain Center
state: Illinois
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Moorestown
country: United States
facility: Phoenix OB GYN Associates
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Jefferson Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Memorial Hermann -Memorial City Medical Center
state: Texas
Study officials:
affiliation: Talphera, Inc
name: Pamela Palmer, M.D., PhD
role: STUDY_DIRECTOR
References:
citation: 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.