Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
Phase 3
Completed
- Conditions
- Acromegaly
- Interventions
- Drug: C2L-OCT-01 PR, 30 mg
- Registration Number
- NCT00616551
- Lead Sponsor
- Ambrilia Biopharma, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A C2L-OCT-01 PR, 30 mg - B Octreotide acetate prolonged release, 30 mg -
- Primary Outcome Measures
Name Time Method Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, 30 mg or Sandostatin LAR 30 mg Days 1, 28, 42, 56 and 84
- Secondary Outcome Measures
Name Time Method Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR 84 days
Trial Locations
- Locations (6)
V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine
🇺🇦Kiev, Ukraine
Republican Centre for Medical Rehabilitation and Water-therapy
🇧🇾Minsk, Belarus
Institute of Endocrinology "C. I. Parhon" Bucharest
🇷🇴Bucharest, Romania
Institute of Endocrinology, University Clinical Center
🇷🇸Belgrade, Serbia
Fakultná Nemocnica s Poliklinkou Bratislava
🇸🇰Bratislava, Slovakia
Semmelweis Egyetem Általános Orvostudományi
🇭🇺Budapest, Hungary