Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly

Ipsen

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acromegaly

Treatments

Drug: Lanreotide (Autogel formulation)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00234572

E-28-52030-717

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of lanreotide autogel to placebo after a single injection. Effectiveness and safety were then also assessed following four fixed-dose injections and after one year of treatment given at titrated doses.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

documentation of a diagnosis of active acromegaly based on either of the following definitions:
1. the patient has never received somatostatin analog nor dopaminergic agonist or had previously received this medication but had stopped more than 3 months before visit 1 and had a mean growth hormone (GH)level >5ng/mL at visit 1; or
2. the patient was receiving treatment with a somatostatin analog (other than lanreotide autogel) or a dopaminergic agonist at visit 1, had a mean GH >3ng/mL at visit 2 (or visit 2a) and had at least a 100% increase in mean GH levels between visit 1 and visit 2 (or visit 2a)

Exclusion criteria

receipt of radiotherapy for acromegaly within 3 years
pituitary surgery within 3 months prior to visit 1
prior receipt of lanreotide autogel or GH antagonist
anticipated need for pituitary surgery (adenomectomy) or radiotherapy during the study period
known hypersensitivity to any of the test materials or related compounds
clinically significant renal or hepatic abnormalities