Aarhus University Hospital
Verified
Aarhus, Denmark
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on patients with polymyalgia rheumatica and giant cell arteritis, who are experiencing a condition known as glucocorticoid-induced adrenal insufficiency. This condition can occur in individuals who are taking a medication called prednisolone, which is a type of steroid used to reduce inflammation. The study aims to explore the effects of an additional treatment with hydrocortisone, a medication that helps the body manage stress, compared to a placebo. The main goal is to see how this treatment affects the quality of life, particularly focusing on feelings of tiredness, during times of physical or mental stress.
Participants in the study will receive either hydrocortisone or a placebo in the form of tablets. The study will monitor how these treatments impact their daily life, especially during stressful situations. The trial will also look at other aspects of health, such as the duration of prednisolone treatment and any changes in symptoms related to adrenal insufficiency. The study will use various questionnaires and assessments to gather information on the participants' experiences and health status.
The trial is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the hydrocortisone or the placebo, to ensure unbiased results. The study will continue for a set period, during which participants will be asked to report their symptoms and any stress they experience. This information will help researchers understand the potential benefits of hydrocortisone in managing symptoms related to adrenal insufficiency in patients with polymyalgia rheumatica and giant cell arteritis.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
5 criteria
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Aarhus, Denmark
Odense, Denmark
Copenhagen, Denmark
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is a medication used in this trial to see if it can help improve the quality of life for patients experiencing stress. It is being tested to see if it can reduce fatigue and help manage symptoms in patients with adrenal insufficiency caused by long-term use of another medication, prednisolone.
is a medication that patients in this trial are already taking for conditions like polymyalgia rheumatica and giant cell arteritis. It is a type of steroid used to reduce inflammation and suppress the immune system. The trial is investigating the effects of adding hydrocortisone to their treatment during times of stress.
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