Trial · NCT05222152
Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency
NCT05222152, Phase 2, Completed, Neurocrine UK Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency. Trials, record NCT05222152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05222152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chronocort Versus Plenadren Replacement Therapy in Adults With Adrenal Insufficiency
- NCT number
- NCT05222152
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Neurocrine UK Limited
- Conditions
- Primary Adrenal Insufficiency
- Interventions
- Chronocort, Plenadren
- First posted
- 2022-02-03
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41552007 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05222152
GET https://conductscience.org/api/trials/v1/NCT05222152/registered?page=2