search
Back to results

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Primary Purpose

Acromegaly

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Octreotide Implant
Sandostatin LAR Depot
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring Octreotide, Sandostatin LAR, Growth hormone, IGF-1

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center - Stanford Hospitals and Clinics
  • University of Colorado - Veterans Administration Medical Center - Endocrinology
  • Galiz Research
  • The University of Illinois at Chicago
  • Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
  • The Cleveland Clinic
  • Oregon Health and Science University, Endocrinology
  • Seattle Neuroscience Institute - Swedish Medical Center
  • 2. interni klinika fakultní nemocnice Hradec Králové
  • 3. interni klinika Vseobecne fakultni nemocnice
  • Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin
  • Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie
  • Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie
  • Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas
  • Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere
  • Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1
  • Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg
  • Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie
  • Semmelweis University, Faculty of Medicine, 2nd Department of Medicine
  • University of Debrecen Medical and Health Science Center, Division of Endocrinology
  • University of Pécs, School of Medicine, 1st Department of Medicine
  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
  • Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
  • Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig
  • Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
  • State Institution of Healthcare "Regional Clinical Hospital"
  • State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
  • State Institution of Healthcare "Kemerovo State Clinical Hospital"
  • Regional State Institution of Healthcare "Regional State Hospital"
  • Federal State Institution "Endocrinology Research Center of Rosmedtechnology"
  • State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development"
  • State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky
  • State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
  • State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
  • State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
  • Center "Diabetes", LLC
  • Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology"
  • National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav"
  • State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
  • Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
  • Institute of Endocrinology
  • Endotopmed s.r.o., Tehelná
  • Národný endokrinologický a diabetologický ústav
  • Hospital General Universitario de Alicante Endocrinología y Nutrición
  • Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
  • Hospital Universitario la Fé Endocrinología y Nutrición

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

84 mg octreotide implant for 6 months

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

Outcomes

Primary Outcome Measures

Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments

Secondary Outcome Measures

Full Information

First Posted
September 30, 2008
Last Updated
September 20, 2013
Sponsor
Endo Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00765323
Brief Title
Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Octreotide, Sandostatin LAR, Growth hormone, IGF-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
84 mg octreotide implant for 6 months
Arm Title
2
Arm Type
Active Comparator
Arm Description
Injections of Sandostatin LAR Depot(20, 30, 40 mg) every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Octreotide Implant
Other Intervention Name(s)
somatostatin analogue
Intervention Description
84 mg octreotide subcutaneous implant for 6 months
Intervention Type
Drug
Intervention Name(s)
Sandostatin LAR Depot
Other Intervention Name(s)
somatostatin analogue
Intervention Description
Injections of Sandostatin LAR (dose range ~10-40 mg every 28 days)
Primary Outcome Measure Information:
Title
Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Stanford University Medical Center - Stanford Hospitals and Clinics
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado - Veterans Administration Medical Center - Endocrinology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Galiz Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
The University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Facility Name
Sinai Hospital of Baltimore, Medicine - Div. of Endocrinology and Metabolism
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health and Science University, Endocrinology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Seattle Neuroscience Institute - Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
2. interni klinika fakultní nemocnice Hradec Králové
City
Hradec Kralove
Country
Czech Republic
Facility Name
3. interni klinika Vseobecne fakultni nemocnice
City
Prague
Country
Czech Republic
Facility Name
Charité Berlin, Campus Benjamin Franklin, Abteilung fϋr Endokrinologie, Diabetes und Ernährungsmedizin
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Medizinische Klinik 1, Gastroenterologie, Pneumologie und Endokrinologie
City
Erlangen
Country
Germany
Facility Name
Klinikum der Johann Wolfgang Goethe-Universität, Medizinische Klinik 1, Endokrinologie
City
Frankfurt
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Bereich Endokrinologie, Diabetologie und Adipositas
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum zu Köln, Klinik und Poliklinik II Innnere
City
Koln
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Medizinische Klinik 1
City
Lubeck
Country
Germany
Facility Name
Klinik für Endokrinologie und Stoffwechselkrankheiten Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
Country
Germany
Facility Name
Klinikum der Philipps Universitaet Marburg Bereich Endokrinologie & Diabetologie
City
Marburg
Country
Germany
Facility Name
Semmelweis University, Faculty of Medicine, 2nd Department of Medicine
City
Budapest
Country
Hungary
Facility Name
University of Debrecen Medical and Health Science Center, Division of Endocrinology
City
Debrecen
Country
Hungary
Facility Name
University of Pécs, School of Medicine, 1st Department of Medicine
City
Pecs
Country
Hungary
Facility Name
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku
City
Gdańsk
Country
Poland
Facility Name
Szpital Kliniczny im. Heliodora Święcickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznań
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Dr n. med. Grzegorz Kulig
City
Szczecin
Country
Poland
Facility Name
Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
City
Warsaw
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wrocławiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
City
Wroclaw
Country
Poland
Facility Name
State Institution of Healthcare "Regional Clinical Hospital"
City
Barnaul
Country
Russian Federation
Facility Name
State Intitution of Healthcare "Mark of Honour "Irkutsk Regional Clinical Hospital"
City
Irkutsk
Country
Russian Federation
Facility Name
State Institution of Healthcare "Kemerovo State Clinical Hospital"
City
Kemerovo
Country
Russian Federation
Facility Name
Regional State Institution of Healthcare "Regional State Hospital"
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Federal State Institution "Endocrinology Research Center of Rosmedtechnology"
City
Moscow
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Moscow Medical Academy named after I.M. Sechenov of Federal Agency of Healthcare and Social Development"
City
Moscow
Country
Russian Federation
Facility Name
State Institution Moscow Regional Scientific-Research Clinical Institute named after M.F. Vladimirsky
City
Moscow
Country
Russian Federation
Facility Name
State Institution of Healthcare "N. Novgorod Regional Clinical Hospital named after N.A. Semashko"
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Novosibirsk State medical Univeristy of Federal Agency of Healthcare and Social Development
City
Novosibirsk
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Perm State Medical Academy named after academician E.A.Vagner of Roszdrav"
City
Perm
Country
Russian Federation
Facility Name
Center "Diabetes", LLC
City
Samara
Country
Russian Federation
Facility Name
Federal State Institution "federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology"
City
St. Petersburg
Country
Russian Federation
Facility Name
National Educational Institution of Additional Professional Education "St. Petersburg Medical Academy of Postgraduate Studies of Roszdrav"
City
St. Petersburg
Country
Russian Federation
Facility Name
State Educational Institution of High Professional Education "Siberian State Medical University of Federal Agency of Healthcare and Social Development"
City
Tomsk
Country
Russian Federation
Facility Name
Municipal Health Care Institution Clinical Hospital for Emergency Medical Care named after N.V. Solovyov
City
Yaroslavl
Country
Russian Federation
Facility Name
Institute of Endocrinology
City
Belgrade
Country
Serbia
Facility Name
Endotopmed s.r.o., Tehelná
City
Bratislava
Country
Slovakia
Facility Name
Národný endokrinologický a diabetologický ústav
City
Lubocna
Country
Slovakia
Facility Name
Hospital General Universitario de Alicante Endocrinología y Nutrición
City
Alicante
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón Endocrinología y Nutrición
City
Madrid
Country
Spain
Facility Name
Hospital Universitario la Fé Endocrinología y Nutrición
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23969184
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

We'll reach out to this number within 24 hrs