A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01539538
First received: February 22, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient Global Satisfaction [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control


Enrollment: 357
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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 q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
Active Comparator: morphine IV PCA Drug: morphine IV PCA
1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

  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), 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
  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: NCT01539538

Locations
United States, Alabama
Eliza Coffee Memorial Hospital
Florence, Alabama, United States, 35630
Drug Research and Analysis Corp
Montgomery, Alabama, United States, 36106
Shoals Medical Trials, Inc
Sheffield, Alabama, United States, 35660
United States, Arizona
Arizona Research Center
Phoenix, Arizona, United States, 85023
United States, California
Lotus Clinical Research
Pasadena, California, United States, 91105
Thorton Hospital
San Diego, California, United States, 92037
United States, Florida
Florida Research Associates, LLC
DeLand, Florida, United States, 32720
River City Clinical Research
Jacksonville, Florida, United States, 32207
Pensacola Research Consultants, Inc
Pensacola, Florida, United States, 32504
Gulfcoast Research Institute
Sarasota, Florida, United States, 34232
Phoenix Clinical Research LLC
Tamarac, Florida, United States, 33321
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Tennessee
Access Clinical Trials
Nashville, Tennessee, United States, 37203
United States, Texas
Endeavor Clinical Trials, PA
San Antonio, Texas, United States, 78229
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
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: NCT01539538     History of Changes
Other Study ID Numbers: IAP309
Study First Received: February 22, 2012
Results First Received: November 25, 2013
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AcelRx Pharmaceuticals, Inc.:
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

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

ClinicalTrials.gov processed this record on October 19, 2014