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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

NCT01660763 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2015-10-20

Study results available
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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.

Conditions

  • Post Operative Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Talphera, Inc

    lead INDUSTRY

Principal Investigators

  • Pamela Palmer, M.D., PhD · Chief Medical Officer, AcelRx Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01660763 on ClinicalTrials.gov