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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001435-33 | EudraCT Number |
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A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.
Six repeated applications of Lanreotide Autogel 120mg administered every 28, 42 or 56 days. For the first three injections, the interval depends on the Octreotide LAR dosage administered previously. The dose interval is titrated after injection 3 depending on the efficacy of the therapy with Lanreotide Autogel
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 28 day dose interval | Experimental |
| |
| 42 day dose interval | Experimental |
| |
| 56 day dose interval | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval | Drug | Six deep subcutaneous injections of Lanreotide Autogel, 24-56 week intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels. | 1 dose interval after the last administration of Lanreotide Autogel 120mg |
| Measure | Description | Time Frame |
|---|---|---|
| Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg which are effective in reducing IGF-1 and GH levels to internationally accepted levels. | Last three injections of Lanreotiude Autogel 120mg | |
| Dose interval, 28, 42 or 56 days for repeated injections of Lanreotide Autogel 120mg, which shows comparable efficacy to the previous treatment with Octreotide LAR 10, 20 or 30 mg in controlling IGF-1 and GH levels |
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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 |
|---|---|---|---|---|---|---|
| Klinikum Innenstadt | Munich | 80336 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21086246 | Result | Schopohl J, Strasburger CJ, Caird D, Badenhoop K, Beuschlein F, Droste M, Plockinger U, Petersenn S; German Lanreotide Study Group. Efficacy and acceptability of lanreotide Autogel(R) 120 mg at different dose intervals in patients with acromegaly previously treated with octreotide LAR. Exp Clin Endocrinol Diabetes. 2011 Mar;119(3):156-62. doi: 10.1055/s-0030-1267244. Epub 2010 Nov 17. |
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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 |
| D000081206 | Duration of Therapy |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Interval between doses after titration in part 2 of treatment (injections 3-6) |
| Patient symptoms and quality of life on Lanreotide Autogel and comparison to previous Octreotide LAR treatment. | 1 dose interval after the last administration of Lanreotide Autogel 120mg |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |