E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy.
B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy. |
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MedDRA Classification |
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 |
This is an exploratory short-term study to assess the effect of cabergoline on cortisol levels in patients with Cushing's disease in the period between diagnosis and surgery and/ or radiotherapy, and in patients not cured by surgery and/or radiotherapy. |
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E.2.2 | Secondary objectives of the trial |
To assess the effects of cabergoline on signs and symptoms caused by hypercortisolism (high blood pressure, hyperglycemia, weight, waist/hip ratio) perceived well-being, and adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with ACTH-dependent Cushings' syndrome who have urinary free cortisol levels at least 20% above the upper reference level either A) prior to surgery and/or radiotherapy or B) post surgery and or radiotherapy
- Informed dated and signed consent - Fertile women most use safe anti-conception |
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E.4 | Principal exclusion criteria |
- Patients with severe hypecortisolism who will require immediate surgery or treatment with other cortisol-lowering medications (metopyrone, ketokonazole or lysodren). - Pregnancy and lactation - Abuse of alcohol or other drugs - Patients who for other reasons are unable to comply with the study protocol - Psychiatric and neurologic symptoms - Moderate to severe hepatic disease - Patients with clinical significant cardiac vavular disease. In the case the patient has responded well to treatment and wishes to continue treatment with cabergoline after the 6-week study period, an echocardiography with assessment of the cardiac valves must be performed before continued treatment. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with a urinary cortisol level below the upper reference level for normal at any time during treatment with cabergoline. |
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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 | Yes |
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 | Yes |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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 | Yes |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |