Overview

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

Status:
Completed
Trial end date:
2008-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ambrilia Biopharma, Inc.
Treatments:
Octreotide
Criteria
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.