Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

Inclusion Criteria: * Subject must be diagnosed with active acromegaly. * If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry. * If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry. * If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable. * If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age. * If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication. * The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions. Exclusion Criteria: * Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating. * Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry. * Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study * Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients * Subject who have any other condition that alters the growth hormone or IGF-1 levels. * Subjects with signs or symptoms related to a tumor compression of the optical chiasm.