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
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|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.
- 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
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
|United States, Maryland|
|Damascus, Maryland, United States|
|Study Director:||Pamela Palmer, M.D., PhD||Chief Medical Officer, AcelRx Pharmaceuticals, Inc.|