NCT01539538View on ClinicalTrials.gov

A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

357

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Post-Operative Pain
Interventions
DRUG

Sufentanil NanoTab PCA System/15 mcg

15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours

DRUG

morphine IV PCA

1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours

Trial Locations (16)

32207

River City Clinical Research, Jacksonville

32504

Pensacola Research Consultants, Inc, Pensacola

32720

Florida Research Associates, LLC, DeLand

33321

Phoenix Clinical Research LLC, Tamarac

34232

Gulfcoast Research Institute, Sarasota

35630

Eliza Coffee Memorial Hospital, Florence

35660

Shoals Medical Trials, Inc, Sheffield

36106

Drug Research and Analysis Corp, Montgomery

37203

Access Clinical Trials, Nashville

43210

The Ohio State University, Columbus

44195

Cleveland Clinic Foundation, Cleveland

78229

Endeavor Clinical Trials, PA, San Antonio

84124

Jean Brown Research, Salt Lake City

85023

Arizona Research Center, Phoenix

91105

Lotus Clinical Research, Pasadena

92037

Thorton Hospital, San Diego

All Listed Sponsors
lead

Talphera, Inc

INDUSTRY

NCT01539538 - A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain | Biotech Hunter | Biotech Hunter