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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00765323
Other study ID # IP107-001
Secondary ID
Status Terminated
Phase Phase 3
First received September 30, 2008
Last updated September 20, 2013
Start date September 2008
Est. completion date June 2011

Study information

Verified date September 2013
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 169
Est. completion date June 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Octreotide Implant
84 mg octreotide subcutaneous implant for 6 months
Sandostatin LAR Depot
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)

Locations

Country Name City State
Czech Republic 2. interni klinika fakultní nemocnice Hradec Králové Hradec Kralove
Czech Republic 3. interni klinika Vseobecne fakultni nemocnice Prague
Germany Charité Berlin, Campus Benjamin Franklin, Abteilung f?r Endokrinologie, Diabetes und Ernährungsmedizin Berlin
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 zu Köln, Klinik und Poliklinik II Innnere Koln
Germany Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1 Lubeck
Germany Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg Magdeburg
Germany Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie Marburg
Hungary 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 Pecs
Poland Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku Gdansk
Poland Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu Poznan
Poland Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig Szczecin
Poland Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ Warsaw
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami Wroclaw
Russian Federation State Institution of Healthcare "Regional Clinical Hospital" Barnaul
Russian Federation State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital" Irkutsk
Russian Federation State Institution of Healthcare "Kemerovo State Clinical Hospital" Kemerovo
Russian Federation Regional State Institution of Healthcare "Regional State Hospital" Krasnoyarsk
Russian Federation Federal State Institution "Endocrinology Research Center of Rosmedtechnology" Moscow
Russian Federation State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development" Moscow
Russian Federation State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky Moscow
Russian Federation State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko" Nizhniy Novgorod
Russian Federation State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development Novosibirsk
Russian Federation State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav" Perm
Russian Federation Center "Diabetes", LLC Samara
Russian Federation Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology" St. Petersburg
Russian Federation National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav" St. Petersburg
Russian Federation State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development" Tomsk
Russian Federation Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov Yaroslavl
Serbia Institute of Endocrinology Belgrade
Slovakia Endotopmed s.r.o., Tehelná Bratislava
Slovakia Národný endokrinologický a diabetologický ústav Lubocna
Spain 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
United States Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism Baltimore Maryland
United States The University of Illinois at Chicago Chicago Illinois
United States The Cleveland Clinic Cleveland Ohio
United States University of Colorado - Veterans Administration Medical Center - Endocrinology Denver Colorado
United States Galiz Research Miami Florida
United States Stanford University Medical Center - Stanford Hospitals and Clinics Palo Alto California
United States Oregon Health and Science University, Endocrinology Portland Oregon
United States Seattle Neuroscience Institute - Swedish Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Germany,  Hungary,  Poland,  Russian Federation,  Serbia,  Slovakia,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments 12 months No
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