Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Phase 2

Completed

• Conditions: Acromegaly
• Interventions: Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

• Registration Number: NCT00088582
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-07-30
• Study First Submitted QC: 2004-07-30
• Study First Posted: 2004-08-02
• Primary Completion: 2005-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pasireotide (SOM230)	Pasireotide (SOM230), Octreotide (Sandostatin)	-
Sandostatin s.c. (Octreotide)	Pasireotide (SOM230), Octreotide (Sandostatin)	-

Primary Outcome Measures

Name	Time	Method
Circulating GH- and IGF-1 concentrations measured every 2 weeks	6 months

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.	Every 3 months

Trial Locations

Locations (5)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

New York University/VA Medical Center; 🇺🇸 New York, New York, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States