This study is currently not recruiting participants.

A Six Month Safety Follow-up Study in Subjects with Eosinophilic Esophagitis (EoE) who Completed Study PR-021 [PR-021: A multicenter randomized double-blind placebo-controlled safety and tolerability phase 1/2a study of two dosing regimens of EUR

Investigation of Glucocorticosteroids Safety and Hypothalamic-Pituitary-Adrenal Axis Effects

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

The focus of this 6 month safety follow-up (Study PR-022) to Study PR-021 will be on glucocorticosteroids-related adverse events and HPA axis suppression.

Detailed description of study

The focus of this 6 month safety follow-up (Study PR-022) to Study PR-021 will be on glucocorticosteroids-related adverse events and HPA axis suppression.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Eosinophilic Esophagitis
  • Age: 100 years or below
  • Gender: All

This study investigates the safety of glucocorticosteroids, focusing on related adverse events and the suppression of the hypothalamic-pituitary-adrenal (HPA) axis. The hypothalamic-pituitary-adrenal axis is a complex set of interactions among the hypothalamus, pituitary gland, and adrenal glands, which helps regulate stress response and other body processes.

Participants will undergo safety assessments to monitor any adverse events related to glucocorticosteroids and evaluate the function of the HPA axis. These assessments are crucial to understanding the long-term effects of glucocorticosteroids on the body.

  • Who can participate: Participants aged 18 to 65 with no history of adrenal disorders or chronic illnesses are eligible.
  • Study details: The study will include regular safety assessments to ensure participant well-being. A placebo may be used to compare effects, defined as an inactive substance given to some participants.
  • Study Timelines: The study will last 6 months.
Updated on 19 Feb 2024. Study ID: 1205008686

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