Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Ipsen

Status and phase

Completed

Phase 3

Conditions

Acromegaly

Treatments

Drug: Lanreotide (Autogel formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00210457

E-54-52030-081

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions:
- patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range,
- patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range.

Exclusion criteria

Patient having had pituitary surgery within the previous 3 months
Patient having received radiotherapy for acromegaly disease within the previous 36 months
Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period
Patient having received lanreotide autogel at any time before the study