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Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

NCT03252353 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-11-23

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, 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).

Conditions

Interventions

DRUG

octreotide capsules

octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)

DRUG

Matching placebo

Matching placebo capsules

Sponsors & Collaborators

  • Chiasma, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan L Samson, MD PhD · Pituitary Center at Baylor St. Luke's Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-06-13
Completion
2022-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Netherlands
  • New Zealand
  • Poland
  • Slovenia
  • Sweden
  • Turkey (Türkiye)
  • 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 NCT03252353 on ClinicalTrials.gov