E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sub Clinical Cushing's Syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011652 |
E.1.2 | Term | Cushing's syndrome |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principle research question is, does mifepristone, a glucocorticoid (steroid) receptor antagonist, improve cardiovascular and biochemical profiles in patients with sub-clinical Cushing's Syndrome, a condition where an abnormally high level of steroids (cortisol) are being produced? |
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E.2.2 | Secondary objectives of the trial |
Are there biochemical markers which predict or explain the response observed with mifepristone in patients with sub-clinical Cushing's Syndrome? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male and over 18 years old or postmenopausal women - Patients have adrenal incidentaloma with benign characteristics as assessed on CT or MRI - Patients lack clinical features classically associated with Cushing's Syndrome - Patients have evidence of excess cortisol as shown by lack of supression of serum cortisol using standard routine tests - Patients are on stable antihypertensive and diabetic medication for two months prior to study entry |
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E.4 | Principal exclusion criteria |
Exclusion criteria include: - evidence of local or systemic malignancy - overt Cushing's Syndrome - servere uncontrolled diabetes mellitus or hypertension - pregnancy - clinically significantly impaired cardiovascular function, severe liver disease, significantly impaired renal function - uncontrolled severe active infection - treatment with approved or experimental drugs which work on the adrenal glands - in women a known history of uterine problems - a requirement for steroids for existing disease - impaired mental capacity or markedly abnormal psychiatric evaluation that precludes informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
the primary outcome measures are: 1) ambulatory and resting blood pressure are 8 weeks 2) 2-hour glucose tolerance at 8 weeks |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
This is an open label pilot study and participation lasts 12 weeks (4 weeks of screening and 8 weeks of intervention). The investigator will meet monthly with the research team to discuss progress and results. It is predicted that that the recruitment period will last 4-6 months and that the full study including data analysis and write up will take a further 1-2months. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |