| - candidate number | 2357 |
| - NTR Number | NTR830 |
| - ISRCTN | Incomplete info for ISRCTN |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 7-dec-2006 |
| - Secondary IDs | 04-09-2007 METC UMC Utrecht |
| - Public Title | Reversibility of adrenal function in Addison's disease. |
| - Scientific Title | Reversibility of adrenal function in Addison's disease. |
| - ACRONYM | N/A |
| - hypothesis | The aim of this study is to investigate reversibility of adrenal function in patients with autoimmune adrenalitis. |
| - Healt Condition(s) or Problem(s) studied | Addison's disease |
| - Inclusion criteria | 1. Patients with Addison's disease; 2. Age: 18-75 years; 3. Stable substitution therapy with glucocorticoids. |
| - Exclusion criteria | 1. Acute stress or illness; 2. Use of other medication containing glucocorticoids; 3. Allergy for synthetic ACTH; 4. Pregnancy; 5. Breast feeding. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | 2 or more arms, non-randomized |
| - Studytype | intervention |
| - planned startdate | 22-dec-2006 |
| - planned closingdate | 1-mrt-2007 |
| - Target number of participants | 30 |
| - Interventions | Performing a Synacthen stimulation test. |
| - Primary outcome | Cortisol concentration 30 and 60 minutes after Synacthen stimulation test. |
| - Secondary outcome | N/A |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | L.C.C.J. Smans |
| - CONTACT for SCIENTIFIC QUERIES | L.C.C.J. Smans |
| - Sponsor/Initiator | University Medical Center Utrecht (UMCU), Department of Endocrinologie |
| - Funding (Source(s) of Monetary or Material Support) | University Medical Center Utrecht (UMCU), Department of Endocrinologie |
| - Publications | N/A |
| - Brief summary | Addison's disease is considered to be a chronic and incurable disease. Patients are treated with glucocorticoids and mineralocorticoids for life with possible side-effects of mild oversubstitution on the long term. It is possible that autoimmune mediated adrenalitis will not always lead to total or permanent destruction of all adrenocortical cells. This study will investigate (partial) reversibility of adrenal function in Addison's disease. |
| - Main changes (audit trail) | |
| - RECORD | 7-dec-2006 - 20-okt-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl