An open-label, cross-over, multi-site, prospective, phase IIb study of effects on circadian rhythms and quality of life of modifieddual-release hydrocortisone Efmody™ versus immediate-release hydrocortisone in patients with Addison’s Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503584-42-00

Enrollment

Registered

2023-07-10

Start date

2023-12-22

Completion date

2024-09-09

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Addison’s Disease

Brief summary

1. To measure the change from baseline in QoL using the Health-related Quality of Life in Addison's disease (AddiQoL) questionnaire, after 11 weeks treatment with Efmody™ compared with immediate-release hydrocortisone [ Time Frame: Baseline and end of each 11 week treatment period. (see protocol section 10.3.1 for further details)

Detailed description

1. To measure the change from baseline in terms of QoL using the 36-Item Short Form Health Survey (SF-36®) questionnaire, after 11 weeks treatment with Efmody™ compared with immediate-release Hydrocortisone. [ Time Frame: Baseline and end of each 11 week treatment period]. See protocol section 10.3.2 for further details

Interventions

DRUGEfmody 10 mg modified-release hard capsules

DRUGHydrocortone 10 mg Tablets

DRUGSolu-Cortef Powder for Solution for Injection or Infusion 100 mg

DRUGEfmody 5 mg modified-release hard capsules

DRUGHydrocortisone 10 mg Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. To measure the change from baseline in QoL using the Health-related Quality of Life in Addison's disease (AddiQoL) questionnaire, after 11 weeks treatment with Efmody™ compared with immediate-release hydrocortisone [ Time Frame: Baseline and end of each 11 week treatment period. (see protocol section 10.3.1 for further details)	—

Secondary

Measure	Time frame
1. To measure the change from baseline in terms of QoL using the 36-Item Short Form Health Survey (SF-36®) questionnaire, after 11 weeks treatment with Efmody™ compared with immediate-release Hydrocortisone. [ Time Frame: Baseline and end of each 11 week treatment period]. See protocol section 10.3.2 for further details	—

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026