Clinical Trial: Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients


	Home	\|	Search	\|	Browse	\|	Resources	\|	Help	\|	What's New	\|	About

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis Pharmaceuticals

Condition	Treatment or Intervention	Phase
Acromegaly	Drug: SOM230 s.c. Drug: Sandostatin s.c.	Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients

Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both

Inclusion Criteria:

Patients with active acromegaly due to a pituitary adenoma
Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study

Exclusion Criteria:

Patients with compression of the optic chiasm causing any visual field defect
Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
Patients who have received radiotherapy in the 2 years prior to the start of the trial
Patients who have congestive heart failure, unstable angina, cardia arrhymia, or a history of acute myocardial infarction within the three months preceding enrollment
Patients with gallstone disease
Patients with chronic liver disease
Known hypersensitivity to Sandostatin or Sandostatin LAR
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
History of immunocompromise, including a positive HIV test result
Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing

California
Cedars Sinai Medical Center, Los Angeles, California, 90048, United States; Not yet recruiting

Shlomo Melmed, MD 310-423-3372 melmed@cshs.org
Shlomo Melmed, MD, Principal Investigator

Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States; Not yet recruiting

Beverly Biller, MD 617-724-3772 bbiller@partners.org
Beverly Biller, MD, Principal Investigator

Michigan
University of Michigan Medical Center, Ann Arbor, Michigan, 48108, United States; Not yet recruiting

Ariel Barkan, MD 734-936-5505 abarkan@umich.edu
Ariel Barkan, MD, Principal Investigator

New York
New York University/VA Medical Center, New York, New York, 10010, United States; Not yet recruiting

David Kleinberg, MD 212-263-4172 david.kleinberg@med.nyu.edu
David Kleinberg, MD, Principal Investigator

Virginia
University of Virginia Health System, Charlottesville, Virginia, 22908, United States; Not yet recruiting

Mary Lee Vance, MD 434-982-3922 mlv@virginia.edu
Mary Lee Vance, MD, Principal Investigator

Australia
Princess Alexandra Hospital, Woolloongabba, 4102, Australia; Not yet recruiting

Ross Cuneo, MD +61732402973 cueno2@medicine.pa.uq.edu.au
Ross Cuneo, MD, Principal Investigator

Belgium, 2650
Universitair Ziekenhaus Antwerpen, Edegem, 2650, Belgium; Not yet recruiting

Roger Abs, MD 00 32 2 821 38 66 roger.abs@uza.be
Roger Abs, MD, Principal Investigator

France
CHU Bicetre, Le Kremlin-Bicetre, 94275, France; Not yet recruiting

Phillipe Chanson, MD 01 45 21 37 08 phillipe.chanson@bct.ap-hop.paris.fr
Phillipe Chanson, MD, Principal Investigator

CHU Rangueil, Toulouse, 31403, France; Not yet recruiting

Phillipe Caron, MD 05 61 32 23 44 caron.p@chu-toulouse.fr
Phillipe Caron, MD, Principal Investigator

CHU La Timone, Marseille, 13385, France; Not yet recruiting

Thiery Brue, MD 04 91 38 77 24 tbrue@ap-hm.fr
Thiery Brue, MD, Principal Investigator

CHRU Angers, Angers, 49033, France; Not yet recruiting

Vincent Rohmer, MD 02 41 35 34 24 Endocrinologie-MedC@chu-angers.fr
Vincent Rohmer, MD, Principal Investigator

CHU Bordeaux, Pessac, 33604, France; Not yet recruiting

Antoine Tabarin, MD 05 57 65 64 24 antoine.tabarin@chu-bordeaux.fr
Antoine Tabarin, MD, Principal Investigator

Hopital Hautepierre Service de M, Strasbourg, 67000, France; Not yet recruiting

Jean-Louis Schlienger, MD 03 88 12 75 97 Jean-Louis.Schlienger@chru-strasbourg.fr
Jean-Louis Schlienger, MD, Principal Investigator

Germany
Universitätsklinikum Essen, ESSEN, 45122, Germany; Recruiting

Stephan Petersenn, MD +49 201 723 2822 stephan.petersenn@uni-essen.de
Stephan Petersenn, MD, Principal Investigator

Universitätklinikum München, Munich, 80336, Germany; Recruiting

Jochen Schopohl, MD +49 89 5160 2330 Jochen.Schopohl@med.uni-muenchen.de
Jochen Schopohl, MD, Principal Investigator

Italy
Presidio Molinette-Az. Ospedaliera S. Giovanni Battista, Torino, 10126, Italy; Not yet recruiting

Enzio Ghigo, MD +39 011 6336041 enzio.ghigo@unito.it
Enzio Ghigo, MD, Principal Investigator

Italy, NA
Il Poloclinico, Il Università degli Studi di Napoli, Napoli, NA, 80131, Italy; Not yet recruiting

Anna Maria Colao, MD +39 081 7462132 colao@unina.it
Anna Maria Colao, MD, Principal Investigator

Netherlands
Erasmus Medisch Centrum (v.h. AZR Dijkzigt), Rotterdam, 3015 GD, Netherlands; Recruiting

A.J. van der Lely, MD +31 10 463 5946 vanderLely@inw3.azr.nl
A.J. van der Lely, MD, Principal Investigator

Leids Universitair Medisch Centrum, Leiden, 2333 ZA, Netherlands; Recruiting

J.A. Romijn, MD +31 71 5262 134 j.a.romijn@lumc.dl
A.J. Romijn, MD, Principal Investigator

Spain
Hospital Clinico San Carlos de Madrid, Madrid, 28040, Spain; Not yet recruiting

Angel Diaz, MD +34 91 330 32 81 joseangeldiaz@mixmail.com
Angel Diaz, MD, Principal Investigator

Hospital Clinico de Barcelona, Barcelona, 08036, Spain; Not yet recruiting

Irene Halperin, MD +34 93 227 55 65 ihalperi@medicina.ub.es

Switzerland
Hospices/Centre Hospitalier Universitaire Vaudois, Lausanne, 1005, Switzerland; Recruiting

Rolf Gaillard, MD 0041 21 314 0600 rolf-christian.gaillard@chuv.hospvd.ch
Rolf Gaillard, MD, Principal Investigator

United Kingdom
Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom; Not yet recruiting

Paul Stewart, MD +44 121 697 8446 p.m.stewart@bham.ac.uk
Paul Stewart, MD, Principal Investigator

Christie Hospital, Manchester, M20 4BX, United Kingdom; Not yet recruiting

Peter J. Trainer, MD +44 161 446 3829 peter.trainer@man.ac.uk