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Safety and Efficacy of Pasireotide Long Acting Release (LAR) vs. Octreotide LAR in Patients With Active Acromegaly
Not Recruiting
Trial ID: NCT00600886
Purpose
The patients received either Pasireotide LAR or Octreotide LAR for one year of treatment.
The objective of this study was to compare the proportion of patients with a reduction of
mean GH level to <2.5 µg/L and the normalization of IGF-1 to within normal limits (age and
sex related) between the two treatment groups (pasireotide LAR and octreotide LAR) at 12
months.
Following one year of treatment patients could proceed into the study extension.
Patients who did not respond to the treatment they were randomized to (based on month 12
assessment results) were switched to the other treatment arm at month 13.
Official Title
A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly
Stanford Investigator(s)
Eligibility
Inclusion criteria:
- Patients with active acromegaly (based on elevated GH and IGF-1 levels)
- Patients who have undergone one or more pituitary surgeries, but have not been treated
medically, or de-novo patients presenting a visible pituitary adenoma on MRI and who
refuse pituitary surgery or for whom pituitary surgery is contraindicated
- Patients for whom written informed consent to participate in the study has been
obtained prior to any study related activity
Exclusion criteria:
- Patients who are being or were treated with octreotide, lanreotide, dopamine agonists
or GH antagonists with the exception of a single dose of short-acting octrotide or
short-acting dopamine agonists. In case of a single dose of short-acting octrotide,
the dose should not be used to predict the response to the octretide treatment. The
single dose of short-acting octreotide or short-acting dopamine agonists should not be
administered in the 3 days prior to randomization
- Patients with compression of the optic chiasm causing any visual field defect
- Patients who have received pituitary irradiation within the last ten years prior to
visit 1
- Poorly controlled diabetic patients
Other protocol-defined inclusion/exclusion criteria may apply
Intervention(s):
drug: Pasireotide
drug: Octreotide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jacob Petralia
6507212830