Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant vs. Sandostatin LAR Depot in Patients With Acromegaly
1 other identifier
interventional
169
9 countries
47
Brief Summary
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2008
Typical duration for phase_3
47 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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 27, 2013
September 1, 2013
2.4 years
September 30, 2008
September 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
12 months
Study Arms (2)
1
ACTIVE COMPARATOR84 mg octreotide implant for 6 months
2
ACTIVE COMPARATORInjections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks
Interventions
84 mg octreotide subcutaneous implant for 6 months
Injections of Sandostatin LAR (dose range \~10-40 mg every 28 days)
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Stanford University Medical Center - Stanford Hospitals and Clinics
Palo Alto, California, 94304, United States
University of Colorado - Veterans Administration Medical Center - Endocrinology
Denver, Colorado, 80220, United States
Galiz Research
Miami, Florida, 33145, United States
The University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
Baltimore, Maryland, 21215, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health and Science University, Endocrinology
Portland, Oregon, 97239, United States
Seattle Neuroscience Institute - Swedish Medical Center
Seattle, Washington, 98122, 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
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
Wroclaw, Poland
National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav"
Saint Petersburg, Russian Federation, Russia
State Institution of Healthcare "Regional Clinical Hospital"
Barnaul, Russia
State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
Irkutsk, Russia
State Institution of Healthcare "Kemerovo State Clinical Hospital"
Kemerovo, Russia
Regional State Institution of Healthcare "Regional State Hospital"
Krasnoyarsk, Russia
Federal State Institution "Endocrinology Research Center of Rosmedtechnology"
Moscow, Russia
State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development"
Moscow, Russia
State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky
Moscow, Russia
State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
Nizhny Novgorod, Russia
State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
Novosibirsk, Russia
State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
Perm, Russia
Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology"
Saint Petersburg, Russia
Center "Diabetes", LLC
Samara, Russia
State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
Tomsk, Russia
Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
Yaroslavl, Russia
Institute of Endocrinology
Belgrade, Serbia
Endotopmed s.r.o., Tehelná
Bratislava, Slovakia
Národný endokrinologický a diabetologický ústav
Lubocna, Slovakia
Hospital General Universitario de Alicante Endocrinología y Nutrición
Alicante, Spain
Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
Madrid, Spain
Hospital Universitario la Fé Endocrinología y Nutrición
Valencia, Spain
Related Publications (1)
Chieffo C, Cook D, Xiang Q, Frohman LA. Efficacy and safety of an octreotide implant in the treatment of patients with acromegaly. J Clin Endocrinol Metab. 2013 Oct;98(10):4047-54. doi: 10.1210/jc.2013-2262. Epub 2013 Aug 22.
PMID: 23969184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
September 1, 2008
Primary Completion
February 1, 2011
Study Completion
June 1, 2011
Last Updated
September 27, 2013
Record last verified: 2013-09