Comparison of Plenadren and Cortsone in newly diagnosed primary adrenal insufficiency

Phase 1

Active, not recruiting

• Conditions: Primary adrenal insufficiency; MedDRA version: 20.0Level: PTClassification code 10052381Term: Primary adrenal insufficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-006487-24-NO
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Age between 16-80 years.

2) Established PAI according to the diagnostic criteria as specified above.

3) Participants must be recently diagnosed, specifically treated with glucocorticoid replacement therapy for less than 21 days prior to inclusion to secure treatment naivety.

4) Participants must be capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 8
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Medical conditions
1) Ongoing treatment for active malignant disease
2) Severe hepatic or renal disease
3) Sever psychiatric disease
4) Chronic abuse of alcohol or drug abuse

Prior/Concomitant Therapy
5) High dose glucocorticoid therapy for other disease during last three months prior to screening. This includes steroid injections for allergic disease and injections into joints. Local glucocorticoid treatment (inhalations, nasal spray or creams for use on skin) is allowed.
6) Prior/Concurrent Clinical Study Experience
7) Participation in another blinded clinical study involving an investigational medicinal product within 1 month prior to study inclusion

Diagnostic Assessments
8) Participants not fulfilling the diagnostic criteria for PAI, as specified above in 5.1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified