Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Phase 3

Completed

• Conditions: Acromegaly

• Registration Number: NCT00499993
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Study Completion: 2003-05
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Growth hormone assessment	At every visit

Secondary Outcome Measures

Name	Time	Method
Safety assessment evaluated by clinical data	At every visit
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
Quality of life	At visit 1 and at the final visit of the study
Lanreotide assessment	At every visit
Clinical symptoms	At every visit
Tumour size	At inclusion and at the final visit of the study
Safety assessment evaluated by laboratory data	At inclusion visit 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

Trial Locations

Locations (24)

Ospedale Maggiore; 🇮🇹 Bologna, Italy

Università deglis Studi di Cagliari; 🇮🇹 Cagliari, Italy

Azienda Ospedaliera "V. Cervello"; 🇮🇹 Palermo, Italy

Ospedale "S. Luigi Gonzaga"; 🇮🇹 Orbassano (TO), Italy

Clinica Medica - Sezione II Medicina Endocrinologia; 🇮🇹 Brescia, Italy

Università degli Studi di Firenze; 🇮🇹 Firenze, Italy

Ospedale Maggiore IRCCS; 🇮🇹 Milano, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Istituto Auxologico; 🇮🇹 Milano, Italy

Ospedale di Niguarda Cà Granda; 🇮🇹 Milano, Italy

Ospedale Garibaldi; 🇮🇹 Catania, Italy

Università degli Studi di Ferrara; 🇮🇹 Ferrara, Italy

D.i.S.E.M. Dipartimento di Scienze Endocrinologiche e Metaboliche; 🇮🇹 Genova, Italy

Università "Federico II" di Napoli; 🇮🇹 Napoli, Italy

Ospedale Cà Foncello; 🇮🇹 Treviso, Italy

Policlinico Agostino Gemelli; 🇮🇹 Roma, Italy

Università degli Studi di Padova; 🇮🇹 Padova, Italy

Ospedale Cisanello; 🇮🇹 Pisa, Italy

Servizio di Endocrinologia; 🇮🇹 Reggio Emilia, Italy

Università "La Sapienza" di Roma; 🇮🇹 Roma, Italy

Istituto di Patologia Speciale Medica e Metodologia Clinica; 🇮🇹 Sassari, Italy

Università degli Studi di Ancona, Ospedale Umberto I; 🇮🇹 Sede Di Torrette (AN) Ancona, Italy

Ospedale Molinette; 🇮🇹 Torino, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Udine, Italy