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Administrative reasons
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The purpose of the protocol is to evaluate the correlation between plasma lanreotide levels and Growth Hormone (GH)/Insulin Like Growth Factor 1 (IGF-1) dynamics and clinical improvement in patients with acromegaly treated with lanreotide Autogel (Somatuline ATG)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | 120 mg administered every 28 days via deep subcutaneous injection. A total of 4 injections will be administered during the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| GH (basal and during Oral Glucose Tolerance Test (OGTT)) and IGF-1 levels, in acromegalic patients previously treated with octreotide long acting release (LAR) 20 mg. | Weeks 16, 18 & 20 | |
| Acromegaly symptoms. | Weeks 16, 18 & 20 | |
| Indices of insulin secretion & sensitivity | Weeks 16, 18 & 20 | |
| Adverse events | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN). | Weeks 16, 18 & 20. | |
| Serum lanreotide Autogel 120 mg concentrations. | Weeks 16, 18 & 20. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Nacional Siglo XXI, IMSS | Mexico City | 06720 | Mexico |
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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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| ECG and gallbladder ultrasound | Week 20 |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |