An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

PHASE2CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

June 30, 2011

Study Completion Date

November 30, 2011

Conditions
Postoperative Pain
Interventions
DRUG

SABER-Bupivacaine Treatment 1a

5.0 ml

DRUG

Placebo SABER-Bupivacaine Treatment 1b

5.0 ml

DRUG

Bupivacaine HCl Treatment 1c

20.0 ml

DRUG

SABER-Bupivacaine Treatment 2a

7.5 ml

DRUG

Placebo SABER-Bupivacaine Treatment 2b

7.5 ml

DRUG

Bupivacaine HCl Treatment 2c

20.0 ml

Trial Locations (10)

1090

Nycomed Investigational Site, Vienna

1130

Nycomed Investigational Site, Vienna

Unknown

Nycomed Investigational Site, Graz

Nycomed Investigational Site, Berlin

Nycomed Investigational Site, Dresden

Nycomed Investigational Site, Marburg

Nycomed Investigational Site, Riga

Nycomed Investigational Site, Valmiera

Nycomed Investigational Site, Lodz

Nycomed Investigational Site, Stockholm

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nycomed

INDUSTRY

lead

Durect

INDUSTRY