Clinical trial NCT00499993: Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly
Official title: Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-07-12
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

* Patients who have undergone pituitary surgery less than 3 months before selection
* Patients previously treated with radiotherapy
* Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months

Primary outcomes:
measure: Growth hormone assessment
timeFrame: At every visit
Secondary outcomes:
measure: Insulin-like Growth Factor 1 (IGF-1) and Acid-Labile Subunit (ALS) assessments
timeFrame: At every visit (with the exception of ALS at study inclusion)
measure: Prolactin (PRL) assessment
timeFrame: At study inclusion, visit 1 and at the final visit of the study
measure: Lanreotide assessment
timeFrame: At every visit
measure: Clinical symptoms
timeFrame: At every visit
measure: Quality of life
timeFrame: At visit 1 and at the final visit of the study
measure: Tumour size
timeFrame: At inclusion and at the final visit of the study
measure: Evaluation of carotid vessels (on an optional basis)
timeFrame: At inclusion and at the final visit of the study
measure: Safety assessment evaluated by clinical data
timeFrame: At every visit
measure: Safety assessment evaluated by laboratory data
timeFrame: At inclusion visit and at the final visit of the study
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Brescia
country: Italy
facility: Clinica Medica - Sezione II Medicina Endocrinologia
city: Cagliari
country: Italy
facility: Università deglis Studi di Cagliari
city: Catania
country: Italy
facility: Ospedale Garibaldi
city: Ferrara
country: Italy
facility: Università degli Studi di Ferrara
city: Firenze
country: Italy
facility: Università degli Studi di Firenze
city: Genova
country: Italy
facility: D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche
city: Milano
country: Italy
facility: Istituto Auxologico
city: Milano
country: Italy
facility: Ospedale Maggiore IRCCS
city: Milano
country: Italy
facility: Ospedale di Niguarda Cà Granda
city: Napoli
country: Italy
facility: Università "Federico II" di Napoli
city: Orbassano (TO)
country: Italy
facility: Ospedale "S. Luigi Gonzaga"
city: Padova
country: Italy
facility: Università degli Studi di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera "V. Cervello"
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Reggio Emilia
country: Italy
facility: Servizio di Endocrinologia
city: Roma
country: Italy
facility: Università "La Sapienza" di Roma
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Sassari
country: Italy
facility: Istituto di Patologia Speciale Medica e Metodologia Clinica
city: Sede Di Torrette (AN) Ancona
country: Italy
facility: Università degli Studi di Ancona, Ospedale Umberto I
city: Torino
country: Italy
facility: Ospedale Molinette
city: Treviso
country: Italy
facility: Ospedale Cà Foncello
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.