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To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide (Autogel formulation) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range | ||
| Mean growth hormone (GH) levels | ||
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Inclusion Criteria:
Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Sud | Amiens | 80054 | France | |||
| Chu d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18248639 | Result | Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31. |
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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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| Number of patients having a serum GH level at or below 2.5ng/ml |
| Number of patients having a serum GH level at or below 1 ng/ml |
| Number of patients with no or reduced clinical signs of acromegaly |
| Long-term safety of repeated injections of lanreotide autogel at titrated doses |
| Angers |
| 49033 |
| France |
| Hôpital de Bois Guillaume | Bois-Guillaume | 76233 | France |
| Chu de la Cote de Nacre | Caen | 14033 | France |
| Hôpital du Bocage | Dijon | 21034 | France |
| Chu de Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| Hôpital du Cluzeau | Limoges | 87042 | France |
| Hôpital Neurologique | Lyon | 69394 | France |
| Hôpital Lapeyronie | Montpellier | 34059 | France |
| Hôpital de l'Archet 1 | Nice | 06202 | France |
| Hôpital du Haut-Levêque | Pessac | 33604 | France |
| Hôpital Maison Blanche | Reims | 51092 | France |
| Hôpital Sud | Rennes | 35056 | France |
| Hôpital Bellevue | Saint-Etienne | 42055 | France |
| Hôpital de Hautepierre | Strasbourg | 67098 | France |
| Hôpital de Rangueil | Toulouse | 31403 | France |
| Centre Hospitalier Vaudois | Lausanne | CH-1011 | Switzerland |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |