Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00088582

Purpose

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

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

Drug Information available for: Octreotide Octreotide acetate Pasireotide

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	48
Study Start Date:	March 2004
Estimated Study Completion Date:	March 2005

Eligibility

Criteria

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 arrhythmia, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088582

Locations

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48108
United States, New York
New York University/VA Medical Center
New York, New York, United States, 10010
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

Novartis

More Information

Study ID Numbers:	CSOM230B2201
Study First Received:	July 30, 2004
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00088582
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Acromegaly, SOM230, Sandostatin

Study placed in the following topic categories:

Bone Diseases, Endocrine
Hypothalamic Diseases
Signs and Symptoms
Pituitary Diseases
Musculoskeletal Diseases
Octreotide

Endocrine System Diseases
Central Nervous System Diseases
Endocrinopathy
Brain Diseases
Bone Diseases
Acromegaly

Additional relevant MeSH terms:

Hyperpituitarism
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009