Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function. This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Novartis Investigative site
A Coruña, Spain
Novartis Investigative site
Alicante, Spain
Novartis Investigative site
Barcelona, Spain
Novartis Investigative site
Burgos, Spain
To evaluate the ability of Sandostatin® LAR® to decrease GH and IGF-I levels in acromegaly patients with micro- or macroadenomas not previously treated
Time frame: at baseline, weeks 12, 24, 48
To evaluate efficacy of Sandostatin® LAR® to reduce the size of micro- or macroadenomas in acromegaly patients with micro- or macroadenomas not previous treated
Time frame: at baseline, weeks 12, 24, 48
To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life.
Time frame: at baseline, weeks 12, 24, 48
To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms
Time frame: at baseline, weeks 12, 24, 48
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Novartis Investigative site
Córdoba, Spain
Novartis Investigative site
Madrid, Spain
Novartis Investigative site
Málaga, Spain
Novartis Investigative site
Tarragona, Spain