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.