Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

CSOM230B2208


NCT ID:

NCT00088608


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

26


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:April 2004
Primary Completion Date:June 2006
Primary Completion Type:Actual
Verification Date:November 2011
Last Changed Date:November 29, 2011
First Received Date:July 30, 2004

Study Outcomes

Outcome Type:Primary Outcome
Measure:Urinary Free Cortisol after 15 days of treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Serum cortisol
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ACTH
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Clinical manifestations
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Tolerability
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Development of biomarkers
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:SOM230 s.c.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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