NCT02096510

Brief Summary

The aim of this study is to compare the effects of tablet treatment, circadian and combined circadian and ultradian subcutaneous hydrocortisone infusion on steroid metabolism and tissue responses to therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 27, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2.7 years

First QC Date

November 28, 2013

Last Update Submit

June 5, 2024

Conditions

Addison DiseaseAdrenal Hyperplasia Congenital

Keywords

Addison DiseaseAdrenal Hyperplasia Congenital

Outcome Measures

Primary Outcomes (1)

  • Serum cortisol -24 hours curve

    admission to hospital for 24 hours

    24 hours

Secondary Outcomes (5)

  • Salivary cortisol - 24 hours curve

    24 hours

  • 24 h urine cortisol and metabolites

    24 hours

  • levels of corticotropic hormone

    24 hours

  • 24 hours curve of tissue cortisol

    24 hours

  • gene expression

    24 hours

Study Arms (3)

continuous subcutaneous hydrocortisone

EXPERIMENTAL

continuous subcutaneous hydrocortisone infusion (CSHI), Solu-Cortef ® 50mg/ml infusate

Drug: Solu-CortefDrug: Cortef

cortef tablets

ACTIVE COMPARATOR

the patient regular treatment by Cortef 5 mg, produced by Nycomed Pharma two times or three times a day.

Drug: Solu-CortefDrug: Cortef

ultradian subcutaneous hydrocortisone

EXPERIMENTAL

ultradian subcutaneous hydrocortisone infusion, Solu-Cortef ® 50mg/ml infusate

Drug: Solu-CortefDrug: Cortef

Interventions

Solu-CortefDRUG

administration by pump for minimum 2 weeks

Also known as: hydrocortisone
continuous subcutaneous hydrocortisonecortef tabletsultradian subcutaneous hydrocortisone
CortefDRUG

tablet treatment 2 ro 3 times per day for 14 days

Also known as: hydrocortisone tablets
continuous subcutaneous hydrocortisonecortef tabletsultradian subcutaneous hydrocortisone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of primary adrenal insufficiency
  • Written informed consent

You may not qualify if:

  • Diabetes mellitus
  • Severe cardiovascular disease
  • Active malignant disease
  • Pregnancy or breast feeding
  • treatment with interfering drugs
  • Intake of grapefruit juice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Helse Bergen

Bergen, 5021, Norway

Location

Related Publications (4)

  • Lightman SL, Conway-Campbell BL. The crucial role of pulsatile activity of the HPA axis for continuous dynamic equilibration. Nat Rev Neurosci. 2010 Oct;11(10):710-8. doi: 10.1038/nrn2914. Epub 2010 Sep 15.

    PMID: 20842176BACKGROUND

  • Lovas K, Husebye ES. Continuous subcutaneous hydrocortisone infusion in Addison's disease. Eur J Endocrinol. 2007 Jul;157(1):109-12. doi: 10.1530/EJE-07-0052.

    PMID: 17609409BACKGROUND

  • Lightman SL, Windle RJ, Julian MD, Harbuz MS, Shanks N, Wood SA, Kershaw YM, Ingram CD. Significance of pulsatility in the HPA axis. Novartis Found Symp. 2000;227:244-57; discussion 257-60. doi: 10.1002/0470870796.ch14.

    PMID: 10752074BACKGROUND

  • Simunkova K, Lovas K, Methlie P, Jovanovic N, Bifulco E, Bronstad I, Lightman SL, Husebye ES, Oksnes M. Pulsatile Subcutaneous Hydrocortisone Replacement in Primary Adrenal Insufficiency. Horm Metab Res. 2023 Jul;55(7):471-478. doi: 10.1055/a-2092-5228. Epub 2023 May 12.

    PMID: 37172949RESULT

MeSH Terms

Conditions

Addison DiseaseAdrenal Hyperplasia, Congenital

Interventions

hydrocortisone hemisuccinateHydrocortisone

Condition Hierarchy (Ancestors)

Adrenal InsufficiencyAdrenal Gland DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesAdrenogenital SyndromeDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSteroid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Katerina Simunkova, MD, PhD

    Universtity of Bergen

    PRINCIPAL INVESTIGATOR

  • Kristian Løvås, MD, PhD

    Helse Bergen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2013

First Posted

March 26, 2014

Study Start

March 27, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

June 7, 2024

Record last verified: 2024-06

Locations

NO(1)