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

Open Label, Randomized Study Comparing the Biological Efficacy & Safety of a New Prolonged Release Formulation of Octreotide Acetate, C2L-OCT-01 PR, 30 mg Administered Every 42 Days for 84 Days With Sandostatin LAR 30 mg Administered Every 28 Days for 84 Days to Acromegalic Patients

The purpose of this study is to assess the biological safety and efficacy of using the drug, C2L-OCT-01 PR, 30 mg to treat 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.