Trial · NCT00422201
Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion
NCT00422201, Phase 2, Terminated, HRA Pharma; results first posted 2013-10-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion. Trials, record NCT00422201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective, Open-Label, Multicenter, International Study of Mifepristone for Symptomatic Treatment of Cushing's Syndrome Caused by Ectopic Adrenal Corticotrophin Hormone (ACTH) Secretion
- NCT number
- NCT00422201
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- HRA Pharma
- Conditions
- Cushing's Syndrome
- Interventions
- Mifepristone
- First posted
- 2007-01-15
- Last updated
- 2019-10-11
- Results first posted
- 2013-10-14
- Limitations and caveats
- As a consequence of the premature study end, analyses performed were primarily descriptive due to the reduced number of enrolled and completed patients.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glycemic Disorders Improved or Normalized | 8 weeks at steady dose | Criteria for improvement or normalization of glycemic disorders: A. For diabetic patients (known or diagnosed at pre-inclusion visit) * Decrease in HbA1c \> 0.3% B. For patients with IGT * Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT \< 7.8 mmol/L (140 mg/dL) D. For patients with IFG If impaired fasting glucose is also associated with impaired glucose tolerance during OGTT at pre-inclusion: \- Normalization of OGTT (2-hour glucose plasma level after 75 g OGTT \< 7.8 mmol/L (140 mg/dL) If impaired fasting glycemia is associated with normal OGTT at pre-inclusion (except at T0): \- Normalization of fasting plasma glucose (fasting plasma glucose \< 5.5 mmol/L (100 mg/dL) |
| Secondary | Features of Cushing's Syndrome | 8 weeks at steady dose | Criteria for secondary glycemic disorder improvement of clinical symptoms attributable to the Cushing's syndrome A. For diabetic patients * Improvement of the following parameters: glycemic profile, fasting blood glucose, fructosamine, 2-hour OGTT (for diabetics diagnosed at screening) * Number of anti-diabetics treatment or dose of anti-diabetics treatment for diabetic patients already on diabetes treatment at inclusion * Doses of insulin for insulin-treated patients B. For patients with IGT * HbA1c * Fructosamine C. For patients with IFG * HbA1c * Fructosamine D. For all patients * Fasting plasma insulin * Area Under the Curve of OGTT results when OGTT performed * HOMA index |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glycemic Disorders Improved or Normalized | 8 weeks at steady dose | 18 patients were recruited. 7 completed the study but only 3 according to the last protocol version (in which primary efficacy criteria were changed), so only these 3 patients were to be analysed | participants | NUMBER |
| SECONDARY | Features of Cushing's Syndrome | 8 weeks at steady dose | 18 patients were recruited. 7 completed the study but only 3 according to the last protocol version, so only these 3 patients were to be analysed | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glycemic Disorders Improved or Normalized | Mifepristone | 2 | participants | ||
| Features of Cushing's Syndrome | Prospective, Open-label, Study of Mifepristone | 2 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single Arm Mifepristone | 18 | |
| Overall Study | COMPLETED | Single Arm Mifepristone | 7 | |
| Overall Study | NOT COMPLETED | Single Arm Mifepristone | 11 |
Source ClinicalTrials.gov
Adverse events99
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Mifepristone | 7 | 17 | 30 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Mifepristone | 9 | 17 | 29 |
| other | Decreased apetite | Metabolism and nutrition disorders | Mifepristone | 4 | 17 | 8 |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 3 |
| other | Dehydratation | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 2 |
| other | Hypernatremia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 1 |
| other | Hypertriglyceridaemia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 1 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 1 |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 1 |
| other | Hyponatraemia | Metabolism and nutrition disorders | Mifepristone | 1 | 17 | 1 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mifepristone | ||
| Total, other adverse events | Mifepristone | 17 | 17 |
| Total, serious adverse events | Mifepristone | 9 | 17 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00422201
GET https://conductscience.org/api/trials/v1/NCT00422201/events?page=2