Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

Inclusion Criteria:

• Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:

  • patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
  • patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

Exclusion Criteria:

• Patient having had pituitary surgery within the previous 3 months
• Patient having received radiotherapy for acromegaly disease within the previous 36 months
• Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
• Patient having received lanreotide autogel at any time before the study