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
1 other identifier
interventional
172
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 postoperative-pain
Started Feb 2012
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 22, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 3, 2014
CompletedOctober 20, 2015
September 1, 2015
11 months
February 22, 2012
October 24, 2013
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
48 hours
Study Arms (2)
Sufentanil NanoTab PCA System/15 mcg
EXPERIMENTALPlacebo Sufentanil NanoTab PCA System
PLACEBO COMPARATORInterventions
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 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.
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) 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 (12)
Surgical Associates of Mobile
Mobile, Alabama, 36607, United States
Caring Clinical Research Corporation
Laguna Hills, California, 92653, United States
The Stamford Hospital
Stamford, Connecticut, 06904, United States
G&G Research
Vero Beach, Florida, 32960, United States
Rush Pain Center
Chicago, Illinois, 60612, United States
CRC of Jackson
Jackson, Mississippi, 39202, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Phoenix OB GYN Associates
Moorestown, New Jersey, 08057, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Jefferson Hospital
Philadelphia, Pennsylvania, 19107, United States
Memorial Hermann -Memorial City Medical Center
Houston, Texas, 77024, United States
Related Publications (1)
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.
PMID: 25318408BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Palmer, MD, PhD
- Organization
- AcelRx Pharmaceuticals, Inc
Study Officials
- STUDY DIRECTOR
Pamela Palmer, M.D., PhD
Talphera, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- 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
February 1, 2012
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
October 20, 2015
Results First Posted
February 3, 2014
Record last verified: 2015-09