Status:
COMPLETED
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acromegaly
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00088582
Start Date
March 1 2004
Last Update
November 7 2016
Active Locations (5)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48108
4
New York University/VA Medical Center
New York, New York, United States, 10010