Last updated on October 2018

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

Cedars-Sinai Medical Center

Los Angeles, CA United States

Stanford University School of Medicine

Stanford, CA United States

University of Colorado Denver

Aurora, CO United States

Emory University

Atlanta, GA United States

Northwestern University

Chicago, IL United States

Johns Hopkins University

Baltimore, MD United States

Massachusetts General Hospital

Boston, MA United States

Washington University School of Medicine

Saint Louis, MO United States

Palm Research Center, Inc.

Las Vegas, NV United States

Rutgers - Robert Wood Johnson Medical School

New Brunswick, NJ United States

Columbia University Medical Center

New York, NY United States

Thomas Jefferson University

Philadelphia, PA United States

Allegheny Endocrinology Associates

Pittsburgh, PA United States

Midstate Endocrinology Associates

Nashville, TN United States

Baylor College of Medicine

Houston, TX United States

Houston Methodist Research Institute

Houston, TX United States

University of Pecs

Pecs, Hungary

H pital Bic tre APHP

Le Kremlin-Bicêtre, France

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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