Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
NCT ID: NCT02685709
Last Updated: 2022-04-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
146 participants
INTERVENTIONAL
2016-02-29
2021-08-31
Brief Summary
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The objective of this study was to compare the efficacy, safety, and patient reported outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands (SRLs).
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Detailed Description
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The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase.
Eligible patients who were biochemically controlled on parenteral SRLs were switched to octreotide capsules for a 26-week period Run-in phase. During this phase the effective dose for each patient was determined through dose titration.
Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening).
Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination.
A Sub-study, performed in selected non-European sites, allowed patients with inadequate biochemical control on octreotide capsules during the Run-in phase to enter a Combination phase and receive co-administration of octreotide capsules with cabergoline tablets for a total of 36 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Run-in phase
Oral octreotide capsules
Octreotide capsules
RCT phase - Oral
Oral octreotide capsules
Octreotide capsules
RCT phase - Injectables
Injectable somatostatin analogs (octreotide or lanreotide)
Octreotide capsules
Combination phase (sub-study)
Octreotide capsules plus cabergoline
Octreotide capsules
Interventions
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Octreotide capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months
* Biochemical control (IGF -1 \< 1.3 x ULN and GH \< 2.5ng/mL)
Exclusion Criteria
* Pituitary radiotherapy within 5 years
* Pituitary surgery within six months
* Patients who previously participated in CH-ACM-01 study
* Any clinically significant uncontrolled concomitant disease
* Symptomatic cholelithiasis
* Previous treatment with:
* Pegvisomant, within 12 weeks
* Dopamine agonists, within 6 weeks
* Pasireotide, within 12 weeks
18 Years
75 Years
ALL
No
Sponsors
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Chiasma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Fleseriu, M.D., FACE
Role: STUDY_CHAIR
Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Keck Medical Center of University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University School of Medicine
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Universitätsklinik für Innere Medizin Klinische Abteilung für Endokrinologie und Diabetologie
Graz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Hospices Civils de Lyon
Bron, , France
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, , France
Praxis für Endokrinologie und Diabetologie Dr M Droste
Oldenburg, , Germany
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
University of Pecs
Pécs, , Hungary
Szegedi Tudományegyetem, I. Belgyógyászati Klinika
Szeged, , Hungary
Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
Monserrato, , Italy
Università di Pisa Dipartimento di Medicina Clinica e Sperimentale
Pisa, , Italy
Fondazione Policlinico Universitario A. Gemelli Università Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo
Rome, , Italy
Hospital of LUHS Kauno Klinikos
Kaunas, , Lithuania
Vaidotas Urbanavicius Individuali Imonė
Vilnius, , Lithuania
Katedra i Klinika Endokrynologii i Chorob Wewnetrznych Gdanski Uniwersytet Medyczny
Gdansk, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
Wroclaw, , Poland
"C.I. Parhon" National Institute of Endocrinology I Clinical Endocrinology Department - Endemic goitier and its complications
Bucharest, , Romania
Antrium Multidisciplinary Medical Clinic
Barnaul, , Russia
Interregional Clinical Diagnostic Center
Kazan', , Russia
Regional State Budgetary Healthcare Institution Regional State Hospital
Krasnoyarsk, , Russia
Sechenov Moscow First State Medical University
Moscow, , Russia
"Atlas" Medical Center
Moscow, , Russia
Vladimirsky Moscow Regional Research Clinical Institute
Moscow, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Federal State Budgetary Institution "V. A. Almazov Federal North-West Medical Research Centre" of the Ministry of Health of the Russian Federation
Saint Petersburg, , Russia
"Centre Diabetes" LLC
Samara, , Russia
Clinical Centre of Serbia, Clinic for Endocrinology Diabetes and Metabolic Diseases
Belgrade, , Serbia
Hospital Universitario de la Ribera
Alzira, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, , Spain
Campus Del Hospital Universitario Virgen del Rocio
Seville, , Spain
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust, Manchester Royal Infirmary
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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Melmed S, Popovic V, Bidlingmaier M, Mercado M, van der Lely AJ, Biermasz N, Bolanowski M, Coculescu M, Schopohl J, Racz K, Glaser B, Goth M, Greenman Y, Trainer P, Mezosi E, Shimon I, Giustina A, Korbonits M, Bronstein MD, Kleinberg D, Teichman S, Gliko-Kabir I, Mamluk R, Haviv A, Strasburger C. Safety and efficacy of oral octreotide in acromegaly: results of a multicenter phase III trial. J Clin Endocrinol Metab. 2015 Apr;100(4):1699-708. doi: 10.1210/jc.2014-4113. Epub 2015 Feb 9.
Melmed S. New therapeutic agents for acromegaly. Nat Rev Endocrinol. 2016 Feb;12(2):90-8. doi: 10.1038/nrendo.2015.196. Epub 2015 Nov 27.
Fleseriu M, Dreval A, Bondar I, Vagapova G, Macut D, Pokramovich YG, Molitch ME, Leonova N, Raverot G, Grineva E, Poteshkin YE, Gilgun-Sherki Y, Ludlam WH, Patou G, Haviv A, Gordon MB, Biermasz NR, Melmed S, Strasburger CJ. Maintenance of response to oral octreotide compared with injectable somatostatin receptor ligands in patients with acromegaly: a phase 3, multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2022 Feb;10(2):102-111. doi: 10.1016/S2213-8587(21)00296-5. Epub 2021 Dec 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about Chiasma
Other Identifiers
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2015-002854-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OOC-ACM-302
Identifier Type: -
Identifier Source: org_study_id
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