A Phase III, Multicentre, Open Label, Comparative, Dose-interval Titration Study Evaluating the Efficacy and Safety of Six Repeated Deep Subcutaneous Administrations of Lanreotide Autogel 120mg, in Acromegalic Patients Previously Treated With Octreotide LAR

NCT00444873 Phase 3 COMPLETED

A multicentre, prospective, open label study of acromegalic patients evaluating the efficacy and safety of different dose-intervals of Lanreotide Autogel 120mg according to international standards and compared to previous treatment with Octreotide LAR 10, 20 or 30 mg.

Details

Lead sponsor	Ipsen
Phase	Phase 3
Status	COMPLETED
Enrolment	38
Start date	2005-01
Completion	2008-01

Conditions

• Acromegaly

Interventions

• lanreotide (Autogel formulation), duration of treatment 24-56 weeks, depending on dose interval

Primary outcomes

• Mean Insulin like Growth Factor 1 (IGF-1) and Growth Hormone (GH) levels at the beginning and end of the study and as proportion of patients conforming to internationally accepted levels. — 1 dose interval after the last administration of Lanreotide Autogel 120mg

Countries

Germany