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Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 Mcg for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01660763
First received: August 7, 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 total unilateral knee or total unilateral hip replacement 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: P3 - 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 Knee or Hip Replacement 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 (SPID48). [ 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. Range of SPID48 scores were -239 to 417.

    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



Enrollment: 419
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: April 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 at least 48 hours. Patients 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 at least 48 hours. Patients 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 of age or older
  • Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid
  • 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 undergone a replacement of the same knee or hip
  • 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
  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: NCT01660763

Locations
United States, Maryland
Deidre Stonestreet
Damascus, Maryland, United States
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Study Director: Pamela Palmer, M.D., PhD Chief Medical Officer, AcelRx Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01660763     History of Changes
Other Study ID Numbers: AcelRx IAP311
Study First Received: August 7, 2012
Results First Received: October 24, 2013
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

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 20, 2014