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A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease

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: NCT00088608
Recruitment Status : Completed
First Posted : August 2, 2004
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE July 30, 2004
First Posted Date  ICMJE August 2, 2004
Last Update Posted Date November 7, 2016
Study Start Date  ICMJE April 2004
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2006)
Urinary Free Cortisol after 15 days of treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2006)
  • Serum cortisol
  • ACTH
  • Clinical manifestations
  • Pharmacokinetics
  • Safety
  • Tolerability
  • Development of biomarkers
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
Official Title  ICMJE A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease
Brief Summary The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cushing's Syndrome
Intervention  ICMJE Drug: SOM230 s.c.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
26
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pituitary Cushing's disease within the two months prior to study entry
  • Patients for whom written informed consent to participate in the study has been obtained
  • Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended

Exclusion Criteria:

  • Female patients who are pregnant or lactating
  • Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
  • Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C > 10
  • Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
  • Patients with chronic liver disease
  • Patients with clotting disorders or abnormal blood counts
  • History of immuno-compromise, including a positive HIV test result
  • Patients with active gall bladder disease
  • Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries France,   Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00088608
Other Study ID Numbers  ICMJE CSOM230B2208
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP