Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

Completed · Phase 3

Conditions studied: Acromegaly

In brief

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide capsules demonstrated sustained biochemical response up to 13 months in patients with acromegaly previously managed with somatostatin analog injections (ref). 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).

Key facts

Study ID

NCT02685709

Run by

Chiasma, Inc.

People needed

146

Starts

2016-02-01

Expected to finish

2021-08-01

Last updated by the study team

2022-04-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of acromegaly
• 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)

You may not qualify if…

• Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.
• 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

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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