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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 Mcg for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01539642
First received: February 22, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

Resource links provided by NLM:


Further study details as provided by AcelRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48). [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 172
Study Start Date: February 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: sufentanil sublingual microtablet system
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.
Other Name: sufentanil sublingual microtablet system

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539642

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

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01539642     History of Changes
Other Study ID Numbers: IAP310
Study First Received: February 22, 2012
Results First Received: October 24, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

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:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Sufentanil
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014