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Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00088582
Recruitment Status : Completed
First Posted : August 2, 2004
Last Update Posted : November 7, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Pasireotide (SOM230), Octreotide (Sandostatin) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2004
Primary Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sandostatin s.c. (Octreotide) Drug: Pasireotide (SOM230), Octreotide (Sandostatin)
Experimental: Pasireotide (SOM230) Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

Primary Outcome Measures :
  1. Circulating GH- and IGF-1 concentrations measured every 2 weeks [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c. [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00088582

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 Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00088582     History of Changes
Other Study ID Numbers: CSOM230B2201
First Posted: August 2, 2004    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs