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

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ClinicalTrials.gov Identifier: NCT01539642

Recruitment Status : Completed

First Posted : February 27, 2012

Results First Posted : February 3, 2014

Last Update Posted : October 20, 2015

Sponsor:

Information provided by (Responsible Party):

AcelRx Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post-Operative Pain	Drug: Sufentanil NanoTab PCA System/15 mcg Drug: Placebo Sufentanil NanoTab PCA System	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	172 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	February 2012
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sufentanil Sufentanil citrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sufentanil NanoTab PCA System/15 mcg	Drug: 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. Other Names: sufentanil sublingual microtablet system Zalviso™
Placebo Comparator: Placebo Sufentanil NanoTab PCA System	Drug: 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.

Outcome Measures

Primary Outcome Measures :

Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). [ Time Frame: 48 hours ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539642

Locations

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United States, Alabama
Surgical Associates of Mobile
Mobile, Alabama, United States, 36607
United States, California
Caring Clinical Research Corporation
Laguna Hills, California, United States, 92653
United States, Connecticut
The Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, Florida
G&G Research
Vero Beach, Florida, United States, 32960
United States, Illinois
Rush Pain Center
Chicago, Illinois, United States, 60612
United States, Mississippi
CRC of Jackson
Jackson, Mississippi, United States, 39202
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Phoenix OB GYN Associates
Moorestown, New Jersey, United States, 08057
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Memorial Hermann -Memorial City Medical Center
Houston, Texas, United States, 77024

Sponsors and Collaborators

AcelRx Pharmaceuticals, Inc.

Investigators

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Study Director:	Pamela Palmer, M.D., PhD	AcelRx Pharmaceuticals, Inc.

More Information

Publications:

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.

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Responsible Party:	AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01539642
Other Study ID Numbers:	IAP310
First Posted:	February 27, 2012 Key Record Dates
Results First Posted:	February 3, 2014
Last Update Posted:	October 20, 2015
Last Verified:	September 2015

Keywords provided by AcelRx Pharmaceuticals, Inc.:


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

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Sufentanil Dsuvia Analgesics, Opioid Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics

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