Status:
COMPLETED
Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
Lead Sponsor:
Ambrilia Biopharma, Inc.
Conditions:
Acromegaly
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00616551
Start Date
April 1 2007
End Date
February 1 2008
Last Update
October 8 2008
Active Locations (6)
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1
Republican Centre for Medical Rehabilitation and Water-therapy
Minsk, Belarus
2
Semmelweis Egyetem Általános Orvostudományi
Budapest, Hungary
3
Institute of Endocrinology "C. I. Parhon" Bucharest
Bucharest, Romania
4
Institute of Endocrinology, University Clinical Center
Belgrade, Serbia