NCT00690898

Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma

Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland. The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life. Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Lanreotide autogel 120 mg	12 months

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2008-06-05
• Last updated: 2022-10-14
• Results posted: 2013-12-23

Locations

27 sites across 9 countries: Belgium, Czechia, Finland, France, Germany, Italy, Netherlands, Turkey (Türkiye), United Kingdom