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NCT02282150UNKNOWNanonymous

Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.

Sponsor

Source record

Ulla Feldt-Rasmussen

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Hydrocortisone, Plenadren

Indication / condition

AI-normalized

Adrenal Insufficiency

Intervention

Source record

Hydrocortisone, Plenadren

Source & freshness

Source record

NCT ID

NCT02282150

Original source

ClinicalTrials.gov

Source last updated

Feb 23, 2017

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT02282150

Title

Effect of Modified-release Compared to Conventional Hydrocortisone on Fatigue, Measured by Ecological Momentary Assessments; a Pilot Study.

Sponsor

Ulla Feldt-Rasmussen

Status

UNKNOWN

Phase

PHASE4

Condition raw

Adrenal Insufficiency

Condition normalized

Adrenal Insufficiency

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Hydrocortisone, Plenadren

Target normalized

Hydrocortisone, Plenadren

Interventions

Hydrocortisone, Plenadren

Public preview

Source record

Despite optimized hydrocortisone replacement regimes, many patients with adrenal insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients report high fatigue levels at certain times during the day. A modified-release hydrocortisone has been shown to improve QoL, particularly fatigue, in patients with primary AI. However, it is unknown, if the same effect can be observed in patients with secondary AI. Further, no studies have evaluated the effect, taking into account the diurnal variation of fatigue. A novel survey method termed Ecological Momentary Assessments (EMA) has the potential to provide reliable measurements of diurnal variations in patient-reported outcomes, such as fatigue. We will compare the effect of modified-release compared to conventional hydrocortisone on fatigue in patients with secondary AI due to pituitary disease, and hereby assess the feasibility of EMA as outcome in future large-scale randomised clinical trials (RCTs).

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