Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

January 8, 2013

Primary Completion Date

August 7, 2015

Study Completion Date

August 7, 2015

Conditions
Dumping Syndrome
Interventions
DRUG

SOM230

Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg

Trial Locations (17)

1200

Novartis Investigative Site, Brussels

3000

Novartis Investigative Site, Leuven

8310

Novartis Investigative Site, Bruges

9000

Novartis Investigative Site, Ghent

10467

Montefiore Medical Center CLCZ696B2320, The Bronx

20246

Novartis Investigative Site, Hamburg

23321

Virginia Endocrinology Research SC, Chesapeake

33604

Novartis Investigative Site, Pessac

55905

Mayo Clinic - Rochester Mayo MN, Rochester

69495

Novartis Investigative Site, Pierre-Bénite

75651

Novartis Investigative Site, Paris

79905

Texas Tech University Health Science Center, El Paso

92037

Ximed Center for Weight Management Ximed Research, La Jolla

94304

Stanford University Medical Center SC - SOM230X2203, Stanford

97080

Novartis Investigative Site, Würzburg

3584CX

Novartis Investigative Site, Utrecht

9713 GZ

Novartis Investigative Site, Groningen

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY