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The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide (Autogel formulation) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with GH control (<5.0 mU.L) and normalised IGF-1 at week 44 compared to the baseline (Week 0) visit. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with GH control (< 5.0 mU/L) at each visit to week 44 compared to the baseline (Week 0) visit. | ||
| The percentage of patients with normalised IGF-1 compared to the baseline visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
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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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| ID | Term |
|---|---|
| C060347 | lanreotide |
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| Change in the GH values compared to the baseline (Week 0) visit. |
| Change in the IGF-1 values compared to the baseline (Week 0) visit. |
| Change in serum lanreotide levels compared to the baseline (Week 0) visit. |
| Change in the serum octreotide levels compared to the baseline visit. |
| Patient evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment. |
| Investigator evaluation of lanreotide Autogel treatment compared with evaluation of octreotide LAR treatment. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |