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| ID | Type | Description | Link |
|---|---|---|---|
| Version 3 | Other Identifier | Protocol Version |
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Check the pharmacodynamics of the drug octreotide acetate LAR 30 mg imported and distributed by Chemical Laboratory Pharmaceutical Bergamo Ltda. compared to the drug Sandostatin LAR ® (octreotide acetate 30 mg) manufactured by Novartis Biociências S / A, using as activity analysis of growth hormone (GH) and growth factor insulin-like 1 (IGF-1 ) after a single dose of the drug in patients with acromegaly
Secondly, it will be observed safety (tolerability) in clinical patients by comparing the clinical and laboratory parameters before and after the study and the incidence of adverse events after a single dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide acetate LAR 30 MG | Experimental | Test |
|
| Sandostatin LAR ® (octreotide acetate LAR) 30 MG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide acetate LAR | Drug | 30 mg, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of serum levels of GH and IGF-I. | Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and severity of side effects during use of the product in order to ensure the security of it. | After drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after. |
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Inclusion Criteria:
- Accept the Terms of Consent;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LAL Clínica Pesquisa e Desenvolvimento Ltda | Valinhos | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| Sandostatin LAR ® (octreotide acetate LAR) 30 MG |
| Drug |
30 mg, single dose |
|
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |