DRUG
Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
108
Locations
29
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 7, 2005
Study start
May 2000
Primary completion
Jan 3, 2003
Study completion
Jan 3, 2003
Results posted
Not reported
Registry updated
Aug 2, 2019
Outcomes
What the study measures.
Primary outcomes
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
Serum IGF-1 levels determined at screening, at weeks 4, 13, 14, 15, 16, 32 & 52, and in the event of early withdrawal
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
29 registered sites.
Czechia · France · Germany · Hong Kong · Hungary · Netherlands · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Baptist Health System Inc
Birmingham, Alabama, United States
Pituitary Center
Los Angeles, California, United States
Northwestern Medical Facility
Chicago, Illinois, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
New York University Medical Center
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Ben Taub Hospital
Houston, Texas, United States
St Ann's Faculty Hospital
Brno, Czechia
University Hospital Charles University
Hradec Králové, Czechia
Charles University
Prague, Czechia
Clinique Marc Linquette
Lille, France
Hôpital Lariboisière - Service de Médecine B
Paris, France
Hôpital Cochin - Service d'Endocrinologie
Paris, France
CHRU de Brabois
Vandœuvre-lès-Nancy, France
Universitätklinikum Charité
Berlin, Germany
Med. Klinik der Universitätat Essen
Essen, Germany
Medizinische Klinik Innenstadt
München, Germany
Queen Mary Hospital
Pokfulam, Hong Kong
Semmelweiss University Medical School
Budapest, Hungary
Semmelweiss University
Budapest, Hungary
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Put the record in context.
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