Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Acromegaly Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00765323
• Other study ID #: IP107-001
• 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

• Acromegaly

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