Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

NCT ID: NCT00765323

Last Updated: 2013-09-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

Acromegaly

Keywords

Octreotide; Sandostatin LAR; Growth hormone; IGF-1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

84 mg octreotide implant for 6 months

Group Type: ACTIVE_COMPARATOR

Octreotide Implant

Intervention Type: DRUG

84 mg octreotide subcutaneous implant for 6 months

2

Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks

Group Type: ACTIVE_COMPARATOR

Sandostatin LAR Depot

Intervention Type: DRUG

Injections of Sandostatin LAR (dose range \~10-40 mg every 28 days)

Interventions

Octreotide Implant

84 mg octreotide subcutaneous implant for 6 months

Intervention Type: DRUG

Sandostatin LAR Depot

Injections of Sandostatin LAR (dose range \~10-40 mg every 28 days)

Intervention Type: DRUG

Other Intervention Names

somatostatin analogue; somatostatin analogue

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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

Countries

United States; Czechia; Germany; Hungary; Poland; Russia; Serbia; Slovakia; Spain

References

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.

Reference Type: DERIVED

PMID: 23969184 (View on PubMed)

Other Identifiers

IP107-001

Identifier Type: -

Identifier Source: org_study_id