Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-001768-30-SE
• Date of registration: 07/12/2005
• Prospective Registration: Yes
• Primary sponsor: EM-kliniken
• Public title: Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ
• Scientific title: Comparison of 2 and 4 doses hydrocortison substitution with regard to plasma concentration and quality of life. - CHEQ
• Date of first enrolment: 04/01/2006
• Target sample size: 12
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001768-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: yes Parallel group: no Cross over: yes Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1) Cortisol plasma level < 300 nmol/L during stimulation test
2) ACTH > 300 ng/L
3) Age > 18 years
4) Informed concent



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

Exclusion criteria:
1) Chronic severe disease with risk of deterioration that can influence the cortisol substitution program
2) Chronic drug abuse
3) suspicion of non compliance


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

We aim to study patients with cortisol deficiency caused by primary adrenal insufficiency (Addison’s disease of autoimmune origin).

Intervention(s)

Product Name: Hydrocortisone
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To study the effects of two different dosing schemes of hydrocortisone on circulating levels of ACTH and cortisol.

Primary end point(s): In a crossover design, six patients are randomised to start treatment with hydrocortisone 20 mg at 0700 hours and 10 mg at 1600 hours. The other six patients start treatment with 10 mg at 0700 hours, 10 mg at 1200 hours, 5 mg at 1600 and 5 mg at 2200 hours. After one month of treatment the patients will switch to the other regimen for one additional month.
During the two-dose regimen the patients will receive placebo at 1200 hours and at 2200 hours.
At the end of each treatment period, the patients will fill out a quality of life assessment form, which include specific questions regarding morning fatigue.

The primary endpoint is ACTH-measurements in the morning before intake of hydrocortisone.

Secondary endpoints are morning levels of IL-6 , morning fatigue and sleeping behaviour.

Secondary Objective: To investigate if interleukin-6 could be used as a marker for the anti inflammatory cortisol effect.
To investigate if quality of life differs between the two schemes used
with regard to fatigue and sleep behaviour.

Secondary ID(s)

HYSS 3