CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 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/NCT01539642
NCT01539642Phase 3Completed
CompareCT.gov

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 Open Abdominal Surgery

Talphera, Inc·interventional·Posted Feb 27, 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 172 participants across 12 sites.

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 open abdominal surgery.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJan 1, 2013
Study CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.3 years ago

Interventions

Sufentanil NanoTab PCA System/15 mcgdrug

15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient 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 up to 48 hours. Patient may elect to remain in study for up to 72 hours.