Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Stopped early · Phase 3
Conditions studied: Acromegaly
In brief
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Key facts
- Study ID
- NCT00765323
- Run by
- Endo USA Inc., a Keenova Therapeutics Company
- People needed
- 169
- Starts
- 2008-09-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2013-09-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients with acromegaly
- Confirmed diagnosis of a growth hormone-secreting tumor
- Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening
- Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 < 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL
You may not qualify if…
- Patients with pituitary surgery less than 3 months prior to screening
- Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c >= 9%
- Symptomatic cholelithiasis
- Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial
- Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
Where it is running
- Stanford University Medical Center - Stanford Hospitals and Clinics — Palo Alto, California, United States
- University of Colorado - Veterans Administration Medical Center - Endocrinology — Denver, Colorado, United States
- Galiz Research — Miami, Florida, United States
- The University of Illinois at Chicago — Chicago, Illinois, United States
- Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism — Baltimore, Maryland, United States
- The Cleveland Clinic — Cleveland, Ohio, United States
- Oregon Health and Science University, Endocrinology — Portland, Oregon, United States
- Seattle Neuroscience Institute - Swedish Medical Center — Seattle, Washington, United States
- 2. interni klinika fakultní nemocnice Hradec Králové — Hradec Králové, Czechia
- 3. interni klinika Vseobecne fakultni nemocnice — Prague, Czechia
- Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin — Berlin, Germany
- Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere — Cologne, Germany
- Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie — Erlangen, Germany
- Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie — Frankfurt, Germany
- Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas — Hamburg, Germany
- Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1 — Lübeck, Germany
- Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg — Magdeburg, Germany
- Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie — Marburg, Germany
- Semmelweis University, Faculty of Medicine, 2nd Department of Medicine — Budapest, Hungary
- University of Debrecen Medical and Health Science Center, Division of Endocrinology — Debrecen, Hungary
- University of Pécs, School of Medicine, 1st Department of Medicine — Pécs, Hungary
- Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku — Gdansk, Poland
- Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu — Poznan, Poland
- Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig — Szczecin, Poland
- Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ — Warsaw, Poland
Full record on ClinicalTrials.gov
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