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Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMS995 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide LAR | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean GH and IGF-I at baseline, week 12, 24 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor volume at baseline, week 24 and 48 | ||
| Signs and symptoms of acromegaly at baseline, week 12, 24 and 48 | ||
| Quality of life and sleep apnea at baseline, week 12, 24 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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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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| Safety and tolerability at any time on treatment |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |