Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
Recruiting
Phase 4
Interventional Study
Adrenal Insufficiency
Polymyalgia Rheumatica
Giant Cell Arteritis
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Marianne Christina Klose · Other
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About This Trial
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insuffi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 50 years
* Women must be postmenopausal (FSH is measured at the screening visit)
* A diagnosis of PMR/GCA, or both conditions combined.
* Treatment with prednisolone ≥12 weeks
* Ongoing prednisolone treatment, with current daily prednisolone dose \> 0 mg and ≤5 mg. The d…
Contacts