Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00088582

Enrollment

Registered

2004-08-02

Start date

2004-03-31

Completion date

Unknown

Last updated

2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Acromegaly, SOM230, Sandostatin

Brief summary

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

Interventions

DRUGPasireotide (SOM230), Octreotide (Sandostatin)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Circulating GH- and IGF-1 concentrations measured every 2 weeks	6 months

Secondary

Measure	Time frame
Safety and efficacy of multiple doses of Pasireotide s.c. and Sandostatin s.c.	Every 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026