Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

November 3, 2016 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48108
        • University of Michigan Medical Center
    • New York
      • New York, New York, United States, 10010
        • New York University/VA Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with active acromegaly due to a pituitary adenoma
  • Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study

Exclusion Criteria:

  • Patients with compression of the optic chiasm causing any visual field defect
  • Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
  • Patients who have received radiotherapy in the 2 years prior to the start of the trial
  • Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
  • Patients with gallstone disease
  • Patients with chronic liver disease
  • Known hypersensitivity to Sandostatin or Sandostatin LAR
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
  • History of immunocompromise, including a positive HIV test result
  • Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
  • Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sandostatin s.c. (Octreotide)
Drug: Pasireotide (SOM230), Octreotide (Sandostatin)
Experimental: Pasireotide (SOM230)
Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Time Frame: Every 3 months
Every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

July 30, 2004

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230B2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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