RECRUITING

Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.

Official Title

A Phase II, Multicenter, Open-label, Non-comparative Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Tolerability of Osilodrostat in Children and Adolescent Patients With Cushing's Syndrome

Quick Facts

Study Start:2021-04-28
Study Completion:2025-11-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03708900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Recordati
CONTACT
+39 0248787456
casi.m@recordati.it
Recordati
CONTACT
+4161 205 61 00

Principal Investigator

Recordati AG
STUDY_DIRECTOR
Recordati AG

Study Locations (Sites)

University of California San Francisco UCSF
San Francisco, California, 94143
United States
National Institute of Child Health and Human Development
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: RECORDATI GROUP

  • Recordati AG, STUDY_DIRECTOR, Recordati AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-28
Study Completion Date2025-11-21

Study Record Updates

Study Start Date2021-04-28
Study Completion Date2025-11-21

Terms related to this study

Keywords Provided by Researchers

  • Cushing's syndrome (CS)
  • LCI699
  • osilodrostat
  • Pituitary Gland
  • Adrenocorticotropic Hormone (ACTH)
  • Urinary Free Cortisol (UFC)
  • mean Urinary Free Cortisol (mUFC)

Additional Relevant MeSH Terms

  • Cushing Syndrome