Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

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 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

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