Clinical trial NCT00765323: Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acromegaly
Keywords: Octreotide
Sandostatin LAR
Growth hormone
IGF-1
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

Detailed description: This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center - Stanford Hospitals and Clinics
state: California
city: Denver
country: United States
facility: University of Colorado - Veterans Administration Medical Center - Endocrinology
state: Colorado
city: Miami
country: United States
facility: Galiz Research
state: Florida
city: Chicago
country: United States
facility: The University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
state: Maryland
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University, Endocrinology
state: Oregon
city: Seattle
country: United States
facility: Seattle Neuroscience Institute - Swedish Medical Center
state: Washington
city: Hradec Kralove
country: Czech Republic
facility: 2. interni klinika fakultní nemocnice Hradec Králové
city: Prague
country: Czech Republic
facility: 3. interni klinika Vseobecne fakultni nemocnice
city: Berlin
country: Germany
facility: Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie
city: Frankfurt
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas
city: Koln
country: Germany
facility: Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere
city: Lubeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1
city: Magdeburg
country: Germany
facility: Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg
city: Marburg
country: Germany
facility: Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie
city: Budapest
country: Hungary
facility: Semmelweis University, Faculty of Medicine, 2nd Department of Medicine
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center, Division of Endocrinology
city: Pecs
country: Hungary
facility: University of Pécs, School of Medicine, 1st Department of Medicine
city: Gdańsk
country: Poland
facility: Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Szczecin
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig
city: Warsaw
country: Poland
facility: Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
city: Barnaul
country: Russian Federation
facility: State Institution of Healthcare "Regional Clinical Hospital"
city: Irkutsk
country: Russian Federation
facility: State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
city: Kemerovo
country: Russian Federation
facility: State Institution of Healthcare "Kemerovo State Clinical Hospital"
city: Krasnoyarsk
country: Russian Federation
facility: Regional State Institution of Healthcare "Regional State Hospital"
city: Moscow
country: Russian Federation
facility: Federal State Institution "Endocrinology Research Center of Rosmedtechnology"
city: Moscow
country: Russian Federation
facility: State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development"
city: Moscow
country: Russian Federation
facility: State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky
city: Nizhniy Novgorod
country: Russian Federation
facility: State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
city: Novosibirsk
country: Russian Federation
facility: State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
city: Perm
country: Russian Federation
facility: State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
city: Samara
country: Russian Federation
facility: Center "Diabetes", LLC
city: St. Petersburg
country: Russian Federation
facility: Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology"
city: St. Petersburg
country: Russian Federation
facility: National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav"
city: Tomsk
country: Russian Federation
facility: State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
city: Yaroslavl
country: Russian Federation
facility: Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
city: Belgrade
country: Serbia
facility: Institute of Endocrinology
city: Bratislava
country: Slovakia
facility: Endotopmed s.r.o., Tehelná
city: Lubocna
country: Slovakia
facility: Národný endokrinologický a diabetologický ústav
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Endocrinología y Nutrición
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
city: Valencia
country: Spain
facility: Hospital Universitario la Fé Endocrinología y Nutrición
Study officials:
References:
citation: 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.