Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00088582
• Other study ID #: CSOM230B2201
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2004
• Last updated: November 3, 2016
• Start date: March 2004

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Pasireotide (SOM230), Octreotide (Sandostatin)

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	New York University/VA Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Petersenn S, Schopohl J, Barkan A, Mohideen P, Colao A, Abs R, Buchelt A, Ho YY, Hu K, Farrall AJ, Melmed S, Biller BM; Pasireotide Acromegaly Study Group.. Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating GH- and IGF-1 concentrations measured every 2 weeks		6 months	Yes
Secondary	Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.		Every 3 months	Yes

External Links

•   Novartis Clinical Trial Results on CSOM230B2201