DRUG
Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Status
Completed
Phase
Phase 2
Enrollment
62
Locations
5
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 2, 2004
Study start
Mar 2004
Primary completion
Oct 2005
Study completion
Not reported
Results posted
Not reported
Registry updated
Nov 7, 2016
Outcomes
What the study measures.
Primary outcomes
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Time frame · 6 months
Secondary outcomes
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Time frame · Every 3 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
5 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
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
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