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

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ClinicalTrials.gov Identifier: NCT01660763
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : February 3, 2014
Last Update Posted : October 20, 2015
Sponsor:
Information provided by (Responsible Party):

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 total unilateral knee or total unilateral hip replacement 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
Study Start Date : August 2012
Primary Completion Date : April 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
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 at least 48 hours. Patients 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 at least 48 hours. Patients may elect to remain in study for up to 72 hours.


Outcome Measures

Primary Outcome Measures :
  1. Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). [ 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. 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



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications:
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01660763     History of Changes
Other Study ID Numbers: IAP311
First Posted: August 9, 2012    Key Record Dates
Results First Posted: February 3, 2014
Last Update Posted: October 20, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sufentanil
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