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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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