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
|Post Operative Pain||Drug: Sufentanil NanoTab PCA System/15 mcg Drug: Placebo Sufentanil NanoTab PCA System||Phase 3|
|Study Design:||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|
- 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
|Study Start Date:||August 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|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.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660763
|United States, Maryland|
|Damascus, Maryland, United States|
|Study Director:||Pamela Palmer, M.D., PhD||Chief Medical Officer, AcelRx Pharmaceuticals, Inc.|