Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Completed · Phase 2
Conditions studied: Acromegaly
In brief
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
Key facts
- Study ID
- NCT00088582
- Run by
- Novartis Pharmaceuticals
- People needed
- 62
- Starts
- 2004-03-01
- Last updated by the study team
- 2016-11-07
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- 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
- University of Virginia Health System — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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