Last updated on September 2017

Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly


Brief description of study

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial, oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). The purpose of this study is to compare the efficacy safety and patient reported outcomes between oral octreotide capsules and injectable somatostatin analogs.

Detailed Study Description

This will be a phase 3, randomized, open-label, active controlled, multicenter study to evaluate maintenance of response, safety and patient reported outcomes (PROs) in acromegaly patients treated with octreotide capsules and in patients treated with SOC parenteral SRLs, who previously tolerated and demonstrated biochemical control on both treatments. The core study will consist of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment Phase (RCT). Eligible patients who are biochemically controlled on parenteral SRLs will be switched to octreotide capsules for a 26-week Run-in phase. During this phase the effective dose for each patient will be determined through dose titration. Patients whose acromegaly is been controlled biochemically on octreotide capsules at the end of the Run-in Phase will enter a 36-week open-label Randomized Controlled Treatment Phase, where they will be 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 will be offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination. A Sub-study, in selected sites, would allow patients with in-adequate 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.

Clinical Study Identifier: NCT02685709

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University of Alabama at Birmingham
Birmingham, AL United States
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Keck Medical Center of University of Southern California
Los Angeles, CA United States
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Cedars-Sinai Medical Center
Los Angeles, CA United States
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Stanford University School of Medicine
Stanford, CA United States
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University of Colorado Denver
Aurora, CO United States
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Emory University
Atlanta, GA United States
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Northwestern University
Chicago, IL United States
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John H. Stroger, Jr. Hospital of Cook County
Chicago, IL United States
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Johns Hopkins University
Baltimore, MD United States
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Massachusetts General Hospital
Boston, MA United States
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Washington University School of Medicine
Saint Louis, MO United States
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Palm Research Center, Inc.
Las Vegas, NV United States
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Rutgers - Robert Wood Johnson Medical School
New Brunswick, NJ United States
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Columbia University Medical Center
New York, NY United States
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The Ohio State University Wexner Medical Center
Columbus, OH United States
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Thomas Jefferson University
Philadelphia, PA United States
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Allegheny Endocrinology Associates
Pittsburgh, PA United States
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Midstate Endocrinology Associates
Nashville, TN United States
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Baylor College of Medicine
Houston, TX United States
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Houston Methodist Research Institute
Houston, TX United States
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Barbara Obermayer-Pietsch, MD

Universit tsklinik f r Innere Medizin Klinische Abteilung f r Endokrinologie und Diabetologie
Graz, Austria
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Anton Luger, MD, PhD

Medizinische Universit t Wien
Wien, Austria
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Gerald Raverot, MD, PhD

Hospices Civils de Lyon
Bron, France
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Phillipe Chanson, MD, PhD

H pital Bic tre APHP
Le Kremlin-Bicêtre, France
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Praxis f r Endokrinologie und Diabetologie Dr M Droste
Oldenburg, Germany
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Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary
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University of Pecs
Pecs, Hungary
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Szegedi Tudom nyegyetem, I. Belgy gy szati Klinika
Szeged, Hungary
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Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
Monserrato, Italy
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Universit di Pisa Dipartimento di Medicina Clinica e Sperimentale
Pisa, Italy
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Fondazione Policlinico Universitario A. Gemelli Universit Cattolica del S.Cuore S.C. Endocrinologia e Malattie del Metabolismo
Rome, Italy
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Robertas Knispelis, MD

Hospital of LUHS Kauno Klinikos
Kaunas, Lithuania
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Vaidotas Urbanavicius, MD, PhD

Vaidotas Urbanavicius Individuali Imon
Vilnius, Lithuania
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