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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C2L-OCT-01 PR, 30 mg | Drug | Administered by deep IM injection (gluteus) on days 1 and 42 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Compare plasma concentrations, efficacy and safety profile of C2L-OCT-01 PR | 84 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Naudin, M.D. | Ambrilia Biopharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Centre for Medical Rehabilitation and Water-therapy | Minsk | Belarus | ||||
| Semmelweis Egyetem Általános Orvostudományi |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| Octreotide acetate prolonged release, 30 mg |
| Drug |
Administered by deep IM (gluteus) on Days 1, 28 and 56 |
|
|
| Budapest |
| Hungary |
| Institute of Endocrinology "C. I. Parhon" Bucharest | Bucharest | Romania |
| Institute of Endocrinology, University Clinical Center | Belgrade | Serbia |
| Fakultná Nemocnica s Poliklinkou Bratislava | Bratislava | Slovakia |
| V.P. Komisarenko Institute of Endocrinology and Metabolism, AMS Ukraine | Kiev | Ukraine |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |