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Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency

NCT05222152 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-05-14

No results posted yet for this study

Summary

This study is a double-blind, double-dummy, two-way cross-over, randomised, Phase II study to be conducted at approximately 6 investigational sites in 2 countries. The study will compare the efficacy, safety and tolerability of twice daily Chronocort, a modified-release hydrocortisone, with once daily Plenadren, a modified-release hydrocortisone, over a treatment period of up to 2 months in participants aged 18 years and over, diagnosed with primary Adrenal Insufficiency (AI).

Conditions

  • Primary Adrenal Insufficiency

Interventions

DRUG

Chronocort

Hydrocortisone modified-release hard gelatin capsules for oral administration - 5mg and 10mg

DRUG

Plenadren

Hydrocortisone modified-release tablets for oral administration - 5mg and 20mg

Sponsors & Collaborators

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • R Ross · Neurocrine UK Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2023-10-18
Completion
2023-10-18

Countries

  • Germany
  • United Kingdom

Study Locations

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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 NCT05222152 on ClinicalTrials.gov