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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT00088608 |
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Date of registration:
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30/07/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
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Scientific title:
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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 |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00088608 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Italy
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cushing's Syndrome
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Intervention(s)
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Drug: SOM230 s.c.
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Primary Outcome(s)
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Urinary Free Cortisol after 15 days of treatment
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Secondary Outcome(s)
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Serum cortisol
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Safety
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ACTH
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Clinical manifestations
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Development of biomarkers
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Tolerability
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Pharmacokinetics
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Secondary ID(s)
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CSOM230B2208
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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