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Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

NCT02685709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-04-22

Study results available
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Summary

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).

Conditions

Interventions

DRUG

Octreotide capsules

Sponsors & Collaborators

  • Chiasma, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Fleseriu, M.D., FACE · Northwest Pituitary Center, Oregon Health & Science University , Portland, OR, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-10-31
Completion
2021-08-31

Countries

  • United States
  • Austria
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685709 on ClinicalTrials.gov