Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
- Conditions
- Acromegaly
- Registration Number
- NCT00234572
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
-
documentation of a diagnosis of active acromegaly based on either of the following definitions:
- 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
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Trial Locations
- Locations (29)
Pituitary Center
🇺🇸Los Angeles, California, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Northwestern Medical Facility
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Ben Taub Hospital
🇺🇸Houston, Texas, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Semmelweiss University Medical School
🇭🇺Budapest, Hungary
Queen Elizabeth Hospital
🇬🇧Edgbaston, Birmingham, United Kingdom
Hôpital Lariboisière - Service de Médecine B
🇫🇷Paris, France
Hôpital Cochin - Service d'Endocrinologie
🇫🇷Paris, France
Baptist Health System Inc
🇺🇸Birmingham, Alabama, United States
University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
New York University Medical Center
🇺🇸New York, New York, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
St Ann's Faculty Hospital
🇨🇿Brno, Czechia
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University Hospital Charles University
🇨🇿Hradec Kralove, Czechia
Charles University
🇨🇿Prague 2, Czechia
Clinique Marc Linquette
🇫🇷Lille, France
CHRU de Brabois
🇫🇷Vandoeuvre-les-Nancy, France
Universitätklinikum Charité
🇩🇪Berlin, Germany
Medizinische Klinik Innenstadt
🇩🇪Munchen, Germany
Semmelweiss University
🇭🇺Budapest, Hungary
Med. Klinik der Universitätat Essen
🇩🇪Essen, Germany
Academic Hospital Leiden
🇳🇱Leiden, Netherlands
Academic Hospital Rotterdam
🇳🇱Rotterdam, Netherlands
The Royal Free Hospital
🇬🇧Hampstead, London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Queen Mary Hospital
🇭🇰Pokfulam, Hong Kong