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CompletedNCT00088582Updated Nov 6, 2016

Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

A Phase 2 interventional study of Pasireotide (SOM230), Octreotide (Sandostatin) in Acromegaly, sponsored by Novartis Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Acromegaly

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Keywords

  • Acromegaly
  • SOM230
  • Sandostatin
03

In context

Acromegaly

196 studies on the registry are indexed under Acromegaly; 18 are open to participants now.

This study's enrollment of 62 is above the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Sandostatin s.c. (Octreotide)

    Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

  • Experimental
    Pasireotide (SOM230)

    Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

Interventions

  • DrugPasireotide (SOM230), Octreotide (Sandostatin)
06

What researchers measure

Primary outcomes

  1. Circulating GH- and IGF-1 concentrations measured every 2 weeks

    Time frame: 6 months

Secondary outcomes

  1. Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.

    Time frame: Every 3 months

07

Study locations

5 sites
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Michigan Medical Center
    Ann Arbor, Michigan 48108, United States
  • New York University/VA Medical Center
    New York, New York 10010, United States
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
08

References and documents

Publications

  • 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, multicenter, phase II trial. J Clin Endocrinol Metab. 2010 Jun;95(6):2781-9. doi: 10.1210/jc.2009-2272. Epub 2010 Apr 21. PubMed 20410233 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00088582
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 2, 2004
Start date
Mar 2004
Primary completion
Oct 2005
Last update
Nov 6, 2016

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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