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.
1 other identifier
interventional
108
8 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2000
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2003
CompletedFirst Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 7, 2005
CompletedAugust 2, 2019
August 1, 2019
2.7 years
October 6, 2005
August 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (29)
Baptist Health System Inc
Birmingham, Alabama, 35213, United States
Pituitary Center
Los Angeles, California, 90048, United States
Northwestern Medical Facility
Chicago, Illinois, 60611, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
New York University Medical Center
New York, New York, 10010, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Oregon Health Sciences University
Portland, Oregon, 97201, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Ben Taub Hospital
Houston, Texas, 77030, United States
St Ann's Faculty Hospital
Brno, Czechia
University Hospital Charles University
Hradec Králové, 500 05, Czechia
Charles University
Prague, 120 00, Czechia
Clinique Marc Linquette
Lille, 59037, France
Hôpital Lariboisière - Service de Médecine B
Paris, 75010, France
Hôpital Cochin - Service d'Endocrinologie
Paris, 75014, France
CHRU de Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitätklinikum Charité
Berlin, 10117, Germany
Med. Klinik der Universitätat Essen
Essen, 45147, Germany
Medizinische Klinik Innenstadt
München, 80336, Germany
Queen Mary Hospital
Pokfulam, Hong Kong
Semmelweiss University Medical School
Budapest, 1088, Hungary
Semmelweiss University
Budapest, 1135, Hungary
Academic Hospital Leiden
Leiden, 2300, Netherlands
Academic Hospital Rotterdam
Rotterdam, 3000, Netherlands
Queen Elizabeth Hospital
Edgbaston, Birmingham, B15 2TH, United Kingdom
The Royal Free Hospital
Hampstead, London, NW3 2QG, United Kingdom
Christie Hospital
Manchester, M204BX, United Kingdom
Related Publications (1)
Melmed S, Cook D, Schopohl J, Goth MI, Lam KS, Marek J. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28. doi: 10.1007/s11102-009-0191-1. Epub 2009 Jul 29.
PMID: 19639415RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 7, 2005
Study Start
May 1, 2000
Primary Completion
January 3, 2003
Study Completion
January 3, 2003
Last Updated
August 2, 2019
Record last verified: 2019-08