Brief Title
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
Brief Summary
5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Circulating GH- and IGF-1 concentrations measured every 2 weeks
Secondary Outcome
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.
Condition
Acromegaly
Intervention
Pasireotide (SOM230), Octreotide (Sandostatin)
Study Arms / Comparison Groups
Sandostatin s.c. (Octreotide)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
62
Start Date
March 2004
Primary Completion Date
October 2005
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00088582
Organization ID
CSOM230B2201
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
November 2016