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

February 22, 2012
February 10, 2014
April 2012
December 2012   (final data collection date for primary outcome measure)
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
Patient satisfaction with method of pain control [ Time Frame: 48 hours after first dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01539538 on ClinicalTrials.gov Archive Site
Not Provided
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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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Post-Operative Pain
  • 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
  • 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
  • Experimental: Sufentanil NanoTab PCA System/15 mcg
    Intervention: Drug: Sufentanil NanoTab PCA System/15 mcg
  • Active Comparator: morphine IV PCA
    Intervention: Drug: morphine IV PCA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01539538
IAP309
No
AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc.
Not Provided
Study Director: Pamela Palmer, M.D., PhD AcelRx Pharmaceuticals, Inc.
AcelRx Pharmaceuticals, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP