Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A
|
Drug: C2L-OCT-01 PR, 30 mg
Administered by deep IM injection (gluteus) on days 1 and 42
|
| Active Comparator: B
|
Drug: Octreotide acetate prolonged release, 30 mg
Administered by deep IM (gluteus) on Days 1, 28 and 56
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR [84 days]
Eligibility Criteria
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.
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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.
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If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
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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.
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Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
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Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
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Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | ||
| 5 | Fakultná Nemocnica s Poliklinkou Bratislava | Bratislava | Slovakia | ||
| 6 | V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine | Kiev | Ukraine |
Sponsors and Collaborators
- Ambrilia Biopharma, Inc.
Investigators
- Study Director: Raphael Naudin, M.D., Ambrilia Biopharma, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C2L-OCT-01 PR-301