The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.
Genders Eligible for Study: Both
Minimum Age Requirement: 18 Years
Maximum Age Requirement: N/A
Inclusion Criteria:
• documentation of a diagnosis of active acromegaly based on either of the following definitions:
1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or
2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)
Exclusion Criteria:
• receipt of radiotherapy for acromegaly within 3 years • pituitary surgery within 3 months prior to visit 1 • prior receipt of lanreotide autogel or GH antagonist • anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period • known hypersensitivity to any of the test materials or related compounds • clinically significant renal or hepatic abnormalities
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