DRUG
A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
Status
Completed
Phase
Phase 2
Enrollment
26
Locations
5
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 2, 2004
Study start
Apr 2004
Primary completion
Jun 2006
Study completion
Not reported
Results posted
Not reported
Registry updated
Nov 7, 2016
Outcomes
What the study measures.
Primary outcomes
Urinary Free Cortisol after 15 days of treatment
Secondary outcomes
Serum cortisol
ACTH
Clinical manifestations
Pharmacokinetics
Safety
Tolerability
Development of biomarkers
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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)
Study locations
5 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Cedars-Sinai Pituitary Center
Los Angeles, California, United States
Massachusetts General Hospital NE Unit
Boston, Massachusetts, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States
Publications
Results and literature.
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Related PeptideStat pages
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