NCT00088608

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

July 30, 2004

Last Update Submit

November 3, 2016

Conditions

Cushing's Syndrome

Outcome Measures

Primary Outcomes (1)

  • Urinary Free Cortisol after 15 days of treatment

Secondary Outcomes (7)

  • Serum cortisol

  • ACTH

  • Clinical manifestations

  • Pharmacokinetics

  • Safety

  • +2 more secondary outcomes

Interventions

SOM230 s.c.DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cedars-Sinai Pituitary Center

Los Angeles, California, 90048, United States

Location

Massachusetts General Hospital NE Unit

Boston, Massachusetts, 02114, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Midwest Endocrinology Associates

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (2)

  • Boscaro M, Ludlam WH, Atkinson B, Glusman JE, Petersenn S, Reincke M, Snyder P, Tabarin A, Biller BM, Findling J, Melmed S, Darby CH, Hu K, Wang Y, Freda PU, Grossman AB, Frohman LA, Bertherat J. Treatment of pituitary-dependent Cushing's disease with the multireceptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial. J Clin Endocrinol Metab. 2009 Jan;94(1):115-22. doi: 10.1210/jc.2008-1008. Epub 2008 Oct 28.

    PMID: 18957506RESULT

  • Trementino L, Cardinaletti M, Concettoni C, Marcelli G, Polenta B, Spinello M, Boscaro M, Arnaldi G. Salivary cortisol is a useful tool to assess the early response to pasireotide in patients with Cushing's disease. Pituitary. 2015 Feb;18(1):60-7. doi: 10.1007/s11102-014-0557-x.

    PMID: 24482099DERIVED

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2004

First Posted

August 2, 2004

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Last Updated

November 7, 2016

Record last verified: 2016-11

Locations

US(5)