Lanreotide Autogel in Patients With Acromegaly Previously Treated With Octreotide LAR

Ipsen

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Lanreotide (Autogel formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00216398

A-9B-52030-159

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety and patient acceptability of Somatuline Autogel in patients with acromegaly previously treated with octreotide LAR.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acromegaly
• The patient must have been tested at Week -4 (4 weeks prior to the Baseline visit) and shown to have a GH level <10 mU/L.
• The patient must have been treated with a stable dose of octreotide LAR for at least four months prior to study entry
• Life expectancy of at least 2 years

Exclusion criteria

• Adenectomy within past 6 months, or likely during study period
• Radiotherapy for acromegalic disease within 1 year, or likely during study period
• Unstable concomitant dopamine agonist therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)