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The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation), duration of treatment 46-48 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Growth hormone assessment | At every visit |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments | At every visit (with the exception of ALS at study inclusion) | |
| Prolactin (PRL) assessment | At study inclusion, visit 1 and at the final visit of the study |
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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 |
|---|---|---|---|---|---|---|
| Ospedali Riuniti di Bergamo | Bergamo | 24128 | Italy | |||
| Ospedale Maggiore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19542735 | Result | Lombardi G, Minuto F, Tamburrano G, Ambrosio MR, Arnaldi G, Arosio M, Chiarini V, Cozzi R, Grottoli S, Mantero F, Bogazzi F, Terzolo M, Tita P, Boscani PF, Colao A. Efficacy of the new long-acting formulation of lanreotide (lanreotide Autogel) in somatostatin analogue-naive patients with acromegaly. J Endocrinol Invest. 2009 Mar;32(3):202-9. doi: 10.1007/BF03346453. |
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| Lanreotide assessment | At every visit |
| Clinical symptoms | At every visit |
| Quality of life | At visit 1 and at the final visit of the study |
| Tumour size | At inclusion and at the final visit of the study |
| Evaluation of carotid vessels (on an optional basis) | At inclusion and at the final visit of the study |
| Safety assessment evaluated by clinical data | At every visit |
| Safety assessment evaluated by laboratory data | At inclusion visit and at the final visit of the study |
| Bologna |
| 40133 |
| Italy |
| Clinica Medica - Sezione II Medicina Endocrinologia | Brescia | 25125 | Italy |
| Università deglis Studi di Cagliari | Cagliari | 09124 | Italy |
| Ospedale Garibaldi | Catania | 95123 | Italy |
| Università degli Studi di Ferrara | Ferrara | 44100 | Italy |
| Università degli Studi di Firenze | Florence | 50134 | Italy |
| D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche | Genova | 16100 | Italy |
| Istituto Auxologico | Milan | 20100 | Italy |
| Ospedale Maggiore IRCCS | Milan | 20122 | Italy |
| Ospedale di Niguarda Cà Granda | Milan | 20162 | Italy |
| Università "Federico II" di Napoli | Naples | 80131 | Italy |
| Ospedale "S. Luigi Gonzaga" | Orbassano (TO) | 10043 | Italy |
| Università degli Studi di Padova | Padova | 35128 | Italy |
| Azienda Ospedaliera "V. Cervello" | Palermo | 90148 | Italy |
| Ospedale Cisanello | Pisa | 56100 | Italy |
| Servizio di Endocrinologia | Reggio Emilia | 42100 | Italy |
| Università "La Sapienza" di Roma | Roma | 00161 | Italy |
| Policlinico Agostino Gemelli | Roma | 00168 | Italy |
| Istituto di Patologia Speciale Medica e Metodologia Clinica | Sassari | 07199 | Italy |
| Università degli Studi di Ancona, Ospedale Umberto I | Sede Di Torrette (AN) Ancona | 60020 | Italy |
| Ospedale Molinette | Torino | 10126 | Italy |
| Ospedale Cà Foncello | Treviso | 31100 | Italy |
| Ospedale Santa Maria della Misericordia | Udine | 33100 | Italy |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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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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