NCT01660763View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

419

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

April 30, 2013

Study Completion Date

May 31, 2013

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.

Trial Locations (1)

Unknown

Deidre Stonestreet, Damascus

All Listed Sponsors
lead

Talphera, Inc

INDUSTRY

NCT01660763 - 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 | Biotech Hunter | Biotech Hunter