CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 419 enrolled
Drug / intervention
Sufentanil NanoTab PCA System/15 mcg +1 moredrug
Likely dose
Sufentanil NanoTab PCA System/15 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01660763
NCT01660763Phase 3Completed
CompareCT.gov

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

Talphera, Inc·interventional·Posted Aug 9, 2012·Updated Oct 20, 2015

In Brief

A Phase 3 clinical trial evaluating Sufentanil NanoTab PCA System/15 mcg and Placebo Sufentanil NanoTab PCA System for Post Operative Pain. Completed, enrolled 419 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Operative Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2012
Enrollment StartAug 1, 2012
Primary CompletionApr 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.9 years ago

Interventions

Sufentanil NanoTab PCA System/15 mcgdrug

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 Sufentanil NanoTab PCA Systemdrug

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.