Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.

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.

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