Trial · NCT05382156
Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome
NCT05382156, Active not recruiting, RECORDATI GROUP
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome. Trials, record NCT05382156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05382156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome
- NCT number
- NCT05382156
- Status
- Active not recruiting
- Enrollment
- 206 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Endogenous Cushing's Syndrome
- Interventions
- Osilodrostat
- First posted
- 2022-05-19
- Last updated
- 2025-11-20
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of osilodrostat-related adverse events and serious adverse events | 3 years of treatment with osilodrostat | Number of participants with Adverse Events and Serious Adverse Events |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Complete response rate: proportion of enrolled patients with mean Urinary Free Cortisol (mUFC) ≤ ULN |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Partial response rate: proportion of enrolled patients with ≥ 50% reduction from baseline in mean urinary free cortisol (mUFC), (but mUFC \> ULN) |
| Secondary | Short and long-term efficacy of osilodrostat | at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years | Overall response rate: proportion of enrolled patients with mean urinary free cortisol (mUFC) ≤ ULN or at least 50% reduction from baseline |
| Secondary | Changes in pituitary tumour size | at baseline before treatment start, after 6 months of treatment, then every 12 months through study completion up to three years | Actual and percentage change from baseline in pituitary tumour size |
| Secondary | Incidence of Adverse Events (Safety and Tolerability) | 3 years of treatment with osilodrostat | Incidence of adverse events and laboratory abnormalities using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale (version 5.0). |
| Secondary | Change of mean urinary free cortisol (mUFC) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in mean urinary free cortisol (mUFC) |
| Secondary | Change of Serum Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Serum Cortisol |
| Secondary | Change of Late Salivary Cortisol | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in Late Salivary Cortisol |
| Secondary | Change of adrenocorticotropic hormone (ACTH) | at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years | Actual and percentage change from baseline in adrenocorticotropic hormone (ACTH) |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05382156
GET https://conductscience.org/api/trials/v1/NCT05382156/registered?page=2