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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
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.
Details
| Lead sponsor | Talphera, Inc |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 419 |
| Start date | 2012-08 |
| Completion | 2013-05 |
Conditions
- Post Operative Pain
Interventions
- Sufentanil NanoTab PCA System/15 mcg
- Placebo Sufentanil NanoTab PCA System
Primary outcomes
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48). — 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
Countries
United States