Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Phase II, Multicentre, Randomized, Double-blind Study in Acromegalic Patients Evaluating the Efficacy and Safety of a Single Deep Subcutaneous Administration of Lanreotide Autogel (60, 90 or 120mg) Versus Placebo Followed by a Single Blind Fixed Dose Phase Evaluating the Pharmacokinetic, Pharmacodynamic, Efficacy and Safety Profile of Multiple Deep Subcutaneous Administrations of Lanreotide Autogel (60, 90 & 120mg) Ending in Open Label Dose Titration Phase.
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.
Phase 2/Phase 3
Mean serum GH levels determined from serial measurements at screening, weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Lanreotide (Autogel formulation)
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
January 3, 2003
Primary Completion Date
January 3, 2003
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
18 Years - N/A
Accepts Healthy Volunteers
Ipsen Medical Director, ,
Ipsen Medical Director, Study Director, Ipsen