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Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Primary Purpose

Acromegaly

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pasireotide (SOM230), Octreotide (Sandostatin)
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, SOM230, Sandostatin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars Sinai Medical Center
  • Massachusetts General Hospital
  • University of Michigan Medical Center
  • New York University/VA Medical Center
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sandostatin s.c. (Octreotide)

Pasireotide (SOM230)

Arm Description

Outcomes

Primary Outcome Measures

Circulating GH- and IGF-1 concentrations measured every 2 weeks

Secondary Outcome Measures

Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.

Full Information

First Posted
July 30, 2004
Last Updated
November 3, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00088582
Brief Title
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly, SOM230, Sandostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sandostatin s.c. (Octreotide)
Arm Type
Experimental
Arm Title
Pasireotide (SOM230)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pasireotide (SOM230), Octreotide (Sandostatin)
Primary Outcome Measure Information:
Title
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Time Frame
Every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Facility Name
New York University/VA Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20410233
Citation
Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM; Pasireotide Acromegaly Study Group. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. J Clin Endocrinol Metab. 2010 Jun;95(6):2781-9. doi: 10.1210/jc.2009-2272. Epub 2010 Apr 21.
Results Reference
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Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

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