Efficacy and Safety Study of Varying Doses of Lanreotide Autogel in Patients With Acromegaly
Completed · Phase 2/Phase 3
Conditions studied: Acromegaly
In brief
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.
Key facts
- Study ID
- NCT00234572
- Run by
- Ipsen
- People needed
- 108
- Starts
- 2000-05-01
- Expected to finish
- 2003-01-03
- Last updated by the study team
- 2019-08-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
- Academic Hospital Leiden — Leiden, Netherlands
Full record on ClinicalTrials.gov
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