Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
This study is ongoing, but not recruiting participants.
First Received: February 9, 2007   Last Updated: April 14, 2009   History of Changes
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00434148
  Purpose

This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.


Condition Intervention Phase
Cushing's Disease
 Drug: Pasireotide
 Phase III

MedlinePlus related topics: Cushing's Syndrome
Drug Information available for: Pasireotide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) sc Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy assessed by urinary free cortisol levels after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of UFC at months 3 and 12 [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
  • Time to first response [ Time Frame: over entire study period ] [ Designated as safety issue: No ]
  • Assessment of plasma ACTH and serum cortisol level [ Time Frame: over entire study period ] [ Designated as safety issue: No ]
  • Assessment of clinical signs and symptoms [ Time Frame: over the entire study period ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: over the entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 162
Study Start Date: December 2006
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
600ug b.i.d: Experimental Drug: Pasireotide
900ug b.i.d: Experimental Drug: Pasireotide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 18 years or greater
  • Confirmed diagnosis of ACTH-dependent Cushing's disease
  • Not considered candidate for pituitary surgery

Exclusion criteria

  • History of pituitary irradiation in the last 10 years
  • Cushing's syndrome not caused by pituitary tumor
  • Patients with active malignant disease (cancer) in the last 5 years
  • Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434148

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford Cancer Center
Stanford, California, United States, 94305
UCLA Med-Endo
Los Angeles, California, United States, 90095
United States, Colorado
Denver Research Institute - VA Medical Center
Denver, Colorado, United States, 80220
United States, Florida
University of Florida - Division of Endocrinology
Gainesville, Florida, United States, 32610
United States, Illinois
University Chicago Hospital
Chicago, Illinois, United States, 60637
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic, Endocrine & Metabolic Institute
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-8857
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Seattle Neuroscience Specialists
Seattle, Washington, United States, 98122
VA Puget Sound Health Care System
Tacoma, Washington, United States, 98493
United States, Wisconsin
Midwest Endocrinology Associates, St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CSOM230B2305
Study First Received: February 9, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00434148     History of Changes
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica;   Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment;   Brazil: National Health Surveillance Agency;   Canada: Health Canada;   China: Ministry of Health;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: German Institute of Medical Documentation and Information;   Greece: National Organization of Medicines;   Italy: The Italian Medicines Agency;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Portugal: National Pharmacy and Medicines Institute;   Spain: Ministry of Health and Consumption;   Turkey: Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United States: Food and Drug Administration

Keywords provided by Novartis:
Cushing's Disease
pasireotide
SOM230

Study placed in the following topic categories:
Hypothalamic Diseases
Pituitary ACTH Hypersecretion
Pituitary Diseases
Cushing Syndrome
Central Nervous System Diseases
Endocrine System Diseases
 Adrenal Gland Diseases
Endocrinopathy
Brain Diseases
Adrenocortical Hyperfunction
Recurrence

Additional relevant MeSH terms:
Hypothalamic Diseases
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Nervous System Diseases
Cushing Syndrome
 Central Nervous System Diseases
Endocrine System Diseases
Adrenal Gland Diseases
Brain Diseases
Adrenocortical Hyperfunction

ClinicalTrials.gov processed this record on May 07, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services