Last updated on October 2018

Efficacy and Safety of Octreotide Capsules (MYCAPSSA) 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 maintenance of biochemical response up to 13 months in the majority of patients with acromegaly previously managed with somatostatin analog injections (reference below).

Detailed Study Description

This is a double blind, randomized study that assesses the efficacy and safety of octreotide capsules vs. placebo. Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks. At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year. Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

Clinical Study Identifier: NCT03252353

Contact Investigators or Research Sites near you

Start Over

Engage Health

University of Alabama at Birmingham
Birmingham, AL United States

Engage Health

Keck Medical Center of University of Southern California
Los Angeles, CA United States

Engage Health

Cedars-Sinai Medical Center
Los Angeles, CA United States

Engage Health

UCLA Medical Center
Los Angeles, CA United States

Engage Health

Stanford University School of Medicine
Palo Alto, CA United States

Engage Health

University of Colorado
Aurora, CO United States

Engage Health

The Emory Clinic
Atlanta, GA United States

Engage Health

Northwestern University
Chicago, IL United States

Engage Health

John H. Stroger Jr. Hospital of Cook County
Chicago, IL United States

Engage Health

Johns Hopkins University Clinical Trials Unit
Baltimore, MD United States

Engage Health

Massachusetts General Hospital
Boston, MA United States

Engage Health

Washington University School of Medicine
Saint Louis, MO United States

Engage Health

Rutgers-Robert Wood Johnson Medical School
New Brunswick, NJ United States

Engage Health

Columbia University Medical Center
New York, NY United States

Engage Health

Memorial Sloan Kettering Cancer Center
New York, NY United States

Engage Health

Cleveland Clinic
Cleveland, OH United States

Engage Health

Ohio State University
Columbus, OH United States

Engage Health

Oregon Health and Science University
Portland, OR United States

Engage Health

Allegheny Endocrinology Associates
Pittsburgh, PA United States

Engage Health

Baylor College of Medicine
Houston, TX United States

Engage Health

Huntsman Cancer Hospital
Salt Lake City, UT United States

Engage Health

University of British Columbia
Vancouver, BC Canada

Engage Health

St Joseph's Health Care
London, ON Canada

Engage Health

McGill University Health Centre
Montreal, QC Canada

Engage Health

Aarhus University Hospital
Aarhus, Denmark

Engage Health

Rigshospitalet The Department of Endocrinology
Copenhagen, Denmark

Engage Health

RWTH Aachen University Hospital, Medical Clinic III Division of Endocrinology and Diabetes
Aachen, Germany

Engage Health

Klinikum der LMU Muenchen, Medizinische Klinik und Poliklinik IV, Endokrinologie
Munich, Germany

Engage Health

Medicover MVZ Oldenburg
Oldenburg, Germany

Engage Health

Magyar Honvedseg Egeszsegugyi Kozpont, II. sz. Belgyogyaszati Osztaly
Budapest, Hungary

Engage Health

Szegedi Tudom nyegyetem, I. Belgy gy szati Klinika
Szeged, Hungary

Engage Health

Hadassah Ein-Karem Medical Center
Jerusalem, Israel

Engage Health

Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel

Engage Health

Tel Aviv Sourasky Medical Center
Tel Aviv, Israel

Engage Health

Policlinico di Monserrato U.O.C. Endocrinologia e Diabetologia
Monserrato, Italy

Engage Health

Azienda Ospedaliero-Universitaria Pisana, Universit di Pisa
Pisa, Italy

Engage Health

Leids Universitair Medisch Centrum
Leiden, Netherlands

Engage Health

Erasmus Medisch Centrum
Rotterdam, Netherlands

Engage Health

Katedra i Klinika Endokrynologii i Chorob Wewnetrznych
Gdansk, Poland

Engage Health

Uniwersyteckie Centrum Okulistyki i Onkologii Samodzielny Publiczny Szpital Kliniczny Slaskiego Uniwersytetu Medycznego w Katowicach, Oddzial Endokrynologii
Katowice, Poland

Engage Health

Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Endokrynologii
Krakow, Poland

Engage Health

Klinika Chorob Wewnetrznych i Endokrynologii
Warszawa, Poland

Engage Health

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Klinika Endokrynologii, Diabetologii i Leczenia Izotopami
Wroclaw, Poland

Engage Health

"C.I. Parhon" National Institute of Endocrinology
Bucharest, Romania

Engage Health

Ankara University, Faculty of Medicine
Ankara, Turkey

Engage Health

Hacettepe University Medical School
Ankara, Turkey

Engage Health

University of Semmelweiss, Budapest
Budapest, Hungary

Engage Health

Thomas Jefferson University Hospital
Philadelphia, PA United States

Engage Health

St Vincent's Private Hospital-NSW
Darlinghurst, Australia

Engage Health

Royal North Shore Public Hospital
St Leonards, Australia

Engage Health

St Vincent's Hospital-VIC
Fitzroy, Australia

Engage Health

The Alfred
Melbourne, Australia

Engage Health

Melbourne Health
Parkville, Australia

Engage Health

Keogh Institute (Sir Charles Gardner)
Nedlands, Australia

Engage Health

Dunedin Hospital
Dunedin, New Zealand

Engage Health

Wellington Hospital
Wellington, New Zealand

Engage Health

University Specialized Hospital for Active Treatment of Endocrinology "Acad. Iv. Pencev" EAD
Sofia, Bulgaria

Engage Health

Pauls Stradins Clinical University Hospital, Endocrinology Center
Riga, Latvia

Engage Health

Riga Eastern Clinical University, Hospital Gailezers Department of Endocrinology
Riga, Latvia

Engage Health

Medical University Centre Ljubljana
Ljubljana, Slovenia

Engage Health

Sahlgrenska University Hospital
Göteborg, Sweden

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.