Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

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

Official Title
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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

Conditions
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Acromegaly

Intervention / Treatment
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* Drug: Pasireotide (SOM230), Octreotide (Sandostatin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sandostatin s.c. (Octreotide)<br> | Drug: Pasireotide (SOM230), Octreotide (Sandostatin)<br> <br> |
| Experimental: Pasireotide (SOM230)<br> | Drug: Pasireotide (SOM230), Octreotide (Sandostatin)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, SOM230, Sandostatin