Trial · NCT05222152
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To measure the change in morning serum cortisol levels from baseline, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | The primary efficacy outcome variable is the 07:00 hour serum cortisol level after 4 weeks of treatment. The treatment effect (Chronocort minus Plenadren, after logarithmic transformation) will be estimated in the efficacy evaluable analysis set (EEAS) (defined as participants with morning serum cortisol assessed at baseline and after each treatment period, with no major protocol violations) using a linear mixed model. |
| Secondary | To measure change in morning fatigue from baseline, using the Multidimensional Assessment of Fatigue (MAF) questionnaire within 1 hr of waking, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | MAF morning fatigue score after 4 weeks of treatment. MAF is a 16 item scale that measures fatigue according to 4 dimensions; degree and severity, distress that it causes, timing of fatigue, and it's impact of various activities of daily living to give a Global Fatigue Score of up to 50, where a higher value equates to more fatigue. |
| Secondary | To measure the change from baseline, in terms of achieving physiological morning cortisol levels after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | Whether or not a participant has achieved a physiological morning cortisol level (defined as the 07:00 hour serum cortisol before the morning dose of \>140 nmol/L after 4 weeks of treatment) will be summarised and compared between treatment periods. Note: a morning cortisol level below 140 nmol/L is considered to reflect relative AI in international guidelines \[Bornstein, 2016\]. |
| Secondary | To measure the change from baseline in terms of closeness of overall salivary cortisone levels during the day to a normal physiological profile, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | A salivary cortisone profile score will be derived at the end of 4 weeks of treatment. The profile score is calculated by comparing the on-study salivary cortisol profile with a profile obtained from healthy volunteers. Five timepoints are compared, where a more similar profile to the normal healthy volunteer profile is preferred. |
| Secondary | To measure the change from baseline in ACTH control in the morning, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | The 07:00 hour plasma ACTH level after 4 weeks of treatment will be summarised and compared between treatment periods. |
| Secondary | To measure the change from baseline to the bone marker of osteocalcin, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | Osteocalcin levels after 4 weeks of treatment will be summarised and compared between treatment periods. |
| Secondary | To measure the change from baseline in morning fatigue using the PROMIS® 7b questionnaire within 1 hour of waking, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | Morning fatigue, using the Patient-Reported Outcomes Measurement Information System (PROMIS® 7b) questionnaire, within 1 hour of waking after 4 weeks of treatment will be summarized and compared between treatment periods. PROMIS 7b is a 7-item scale that measures self-reported fatigue that may impact daily activities and normal functioning. A higher PROMIS 7b score indicates greater fatigue and therefore a less favorable outcome. |
| Secondary | To measure the change from baseline in QoL using the EuroQol 5-level Standardized Health Questionnaire (EQ-5D-5L™), after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | QoL, using the EQ-5D-5L after 4 weeks of treatment, will be summarized and compared between treatment periods. The scale measures on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Where the minimum score is 0 and maximum score is 100, a high score indicates a more favorable outcome. |
| Secondary | To measure the change from baseline in QoL using the Health-related Quality of Life in Addison's disease (AddiQoL) questionnaire, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | QoL, using the AddiQoL questionnaire after 4 weeks of treatment, will be summarized and compared between treatment periods. AddiQoL is a 30 item scale measuring health-related quality of life in Addison's disease. A higher score indicates a higher quality of life and therefore a more favorable outcome. |
| Secondary | To measure the change from baseline in terms of QoL using the 36-Item Short Form Health Survey (SF-36®) questionnaire, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | QoL, using SF-36 questionnaire after 4 weeks of treatment, will be summarized and compared between treatment periods. Analyses of SF-36 at other timepoints are exploratory analyses. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). All components contribute in different proportions to the overall measures. Where the minimum score is 0 and maximum score is 100 and a high score is a more favorable score. |
| Other | To measure the change in terms of activity, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | After the end of each 4 week treatment period. | Mean daily steps, mean steps between 07:00-15:00 hours, and mean steps between 15:00-23:00 hours, as assessed by a wearable device, will be summarized and compared between treatment periods, where more steps, i.e. more activity is considered preferable. |
| Other | To measure the change in terms of sleep, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | After the end of each 4 week treatment period. | Mean sleep hours, mean rapid eye movement (REM) sleep, mean light sleep, and mean deep sleep, as assessed by a wearable device, will be summarized and compared between treatment periods, where greater length of sleep is considered preferable. |
| Other | To measure the change from baseline in terms of QoL using the Diurnal Alertness visual analogue scale (VAS), after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | QoL, using the Diurnal Alertness VAS, after 4 weeks of treatment and at other timepoints will be summarized and compared between treatment periods. QoL will be assessed using a Visual Analog Scale (VAS), which is a 10cm scale ranging from 'Brain Fog: unable to perform normal daily tasks' to 'Fully Alert: able to perform normal daily tasks easily'. A higher score indicates a better outcome. |
| Other | To measure the change from baseline in terms of QoL using the General Anxiety Disorder-7 (GAD-7) scale, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | The GAD-7 scale is a screening tool and symptom severity measure for the seven most common anxiety disorders. QOL measured using the GAD-7 scale after 4 weeks of treatment and at other timepoints will be summarized and compared between treatment periods. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions, where a lower score indicates a better outcome. |
| Other | To measure the change from baseline in terms of QoL using the Patient Health Questionnaire-9 (PHQ-9) scale, after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | The PHQ-9 is a self-administered assessment scale for the evaluation of depression symptoms. QoL, using the PHQ-9 scale, after 4 weeks of treatment and at other timepoints will be summarized and compared between treatment periods. The PHQ-9 scale consists of 9 questions, each with a score of 0-3, with 0 meaning Not at All, 1 meaning Several Days, 2 meaning More than half of the days and 3 Nearly every day. As the score increases then this is indicative of a more serious depressive disorder. There is a 10th question which is only answered if one of the scores for questions 1 to 9 are 1 or more. |
| Other | To measure the change from baseline in terms of QoL using the Gissen Complaints Questionnaire-24 (GBB-24) scale (German participants only), after 4 weeks treatment with Chronocort compared with 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | The GBB-24 scale measures self reported physical complaints in terms of whether the issue is fully or partially psychosomatically induced. QoL, using the GBB-24 scale, after 4 weeks of treatment and at other timepoints will be summarized and compared between treatment periods. The GBB-24 consists of 24 different health complaints, the severity of each is rated according to a five point scale; 0 (not at all), 1 (slightly), 2 (somewhat), 3 (considerably) and 4 (very much) \[23\]. The complaints are grouped and summarized into four subscales with six complaints in each of the following groups: Cardiovascular complaints, gastrointestinal complaints, musculoskeletal complaints and exhaustion, where a lower score indicates a more favorable outcome. |
| Other | To assess the participant's preference to treatment, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | After the end of each 4 week treatment period. | Participant preference for assigned treatment during Treatment Period 1 relative to pre-study treatment, and for assigned treatment during Treatment Period 2 relative to that during Treatment Period 1, will be summarised and compared between treatments. |
| Other | To assess treatment compliance, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | After the end of each 4 week treatment period. | The percentage treatment compliance between visits and overall will be summarised. |
| Other | To measure change in terms of safety and tolerability, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | After the end of each 4 week treatment period. | The incidence, nature, severity, relatedness, duration, outcome, seriousness, and expectedness of treatment-emergent adverse events (TEAEs) will be tabulated by treatment period. |
| Other | To measure change from baseline in terms of blood pressure, after 4 weeks treatment with Chronocort compared to 4 weeks treatment with Plenadren (crossover study). | Baseline and end of each 4 week treatment period. | Blood pressure after 4 weeks of treatment will be summarised and compared between treatment periods. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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