Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

September 20, 2013 updated by: Endo Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic
        • 2. interni klinika fakultní nemocnice Hradec Králové
      • Prague, Czech Republic
        • 3. interni klinika Vseobecne fakultni nemocnice
  • Germany
      • Berlin, Germany
        • Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin
      • Erlangen, Germany
        • Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie
      • Frankfurt, Germany
        • Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas
      • Koln, Germany
        • Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere
      • Lubeck, Germany
        • Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1
      • Magdeburg, Germany
        • Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg
      • Marburg, Germany
        • Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie
  • Hungary
      • Budapest, Hungary
        • Semmelweis University, Faculty of Medicine, 2nd Department of Medicine
      • Debrecen, Hungary
        • University of Debrecen Medical and Health Science Center, Division of Endocrinology
      • Pecs, Hungary
        • University of Pécs, School of Medicine, 1st Department of Medicine
  • Poland
      • Gdańsk, Poland
        • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
      • Poznań, Poland
        • Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
      • Szczecin, Poland
        • Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig
      • Warsaw, Poland
        • Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
      • Wroclaw, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • Russian Federation
      • Barnaul, Russian Federation
        • State Institution of Healthcare "Regional Clinical Hospital"
      • Irkutsk, Russian Federation
        • State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
      • Kemerovo, Russian Federation
        • State Institution of Healthcare "Kemerovo State Clinical Hospital"
      • Krasnoyarsk, Russian Federation
        • Regional State Institution of Healthcare "Regional State Hospital"
      • Moscow, 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
      • Nizhniy Novgorod, Russian Federation
        • State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
      • Novosibirsk, Russian Federation
        • State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
      • Perm, Russian Federation
        • State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
      • Samara, Russian Federation
        • Center "Diabetes", LLC
      • St. Petersburg, 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"
      • Tomsk, Russian Federation
        • State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
      • Yaroslavl, Russian Federation
        • Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
  • Serbia
      • Belgrade, Serbia
        • Institute of Endocrinology
  • Slovakia
      • Bratislava, Slovakia
        • Endotopmed s.r.o., Tehelná
      • Lubocna, Slovakia
        • Narodny Endokrinologicky a diabetologicky ustav
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante Endocrinología y Nutrición
      • Madrid, Spain
        • Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
      • Valencia, Spain
        • Hospital Universitario la Fé Endocrinología y Nutrición
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center - Stanford Hospitals and Clinics
    • Colorado
      • Denver, Colorado, United States, 80220
        • University of Colorado - Veterans Administration Medical Center - Endocrinology
    • Florida
      • Miami, Florida, United States, 33145
        • Galiz Research
    • Illinois
      • Chicago, Illinois, United States, 60608
        • The University of Illinois at Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University, Endocrinology
    • Washington
      • Seattle, Washington, United States, 98122
        • Seattle Neuroscience Institute - Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
84 mg octreotide implant for 6 months
Drug: Octreotide Implant
84 mg octreotide subcutaneous implant for 6 months
Other Names:
  • somatostatin analogue
Active Comparator: 2
Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks
Drug: Sandostatin LAR Depot
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
Other Names:
  • somatostatin analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

September 27, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP107-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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