NCT01539642View on ClinicalTrials.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

PHASE3CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

January 31, 2013

Study Completion Date

February 28, 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 up to 48 hours. Patient 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 up to 48 hours. Patient may elect to remain in study for up to 72 hours.

Trial Locations (12)

11215

New York Methodist Hospital, Brooklyn

19107

Jefferson Hospital, Philadelphia

27710

Duke University Medical Center, Durham

32960

G&G Research, Vero Beach

36607

Surgical Associates of Mobile, Mobile

39202

CRC of Jackson, Jackson

60612

Rush Pain Center, Chicago

77024

Memorial Hermann -Memorial City Medical Center, Houston

92653

Caring Clinical Research Corporation, Laguna Hills

06904

The Stamford Hospital, Stamford

08103

Cooper University Hospital, Camden

08057

Phoenix OB GYN Associates, Moorestown

All Listed Sponsors
lead

Talphera, Inc

INDUSTRY

NCT01539642 - 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 | Biotech Hunter | Biotech Hunter