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

Ipsen

Status and phase: Completed; Phase 3

Conditions: Acromegaly

Treatments: Drug: lanreotide (Autogel formulation), duration of treatment 46-48 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00499993

A-93-52030-077

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)