Current partner codePEPTIDESDE
NCT00088608·Phase 2·INTERVENTIONAL

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.

DRUG

SOM230 s.c.

Timeline

From registration to results.

  1. First posted

    Aug 2, 2004

  2. Study start

    Apr 2004

  3. Primary completion

    Jun 2006

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. 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

Related trials

More studies on Pasireotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.