Brief Title
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Official Title
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.
Brief Summary
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
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
Secondary Outcome
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Condition
Acromegaly
Intervention
Lanreotide (Autogel formulation)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
108
Start Date
May 2000
Completion Date
January 3, 2003
Primary Completion Date
January 3, 2003
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT00234572
Organization ID
E-28-52030-717
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
August 2019