Clinical trial NCT00088582: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Keywords: Acromegaly
SOM230
Sandostatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-08-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Circulating GH- and IGF-1 concentrations measured every 2 weeks
timeFrame: 6 months
Secondary outcomes:
measure: Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
timeFrame: Every 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: New York
country: United States
facility: New York University/VA Medical Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.