E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients.
10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone. |
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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 | LLT |
E.1.2 | Classification code | 10021067 |
E.1.2 | Term | Hypopituitarism |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033662 |
E.1.2 | Term | Panhypopituitarism |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057217 |
E.1.2 | Term | Isolated ACTH deficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
We aim to define the most appropriate physiological dose of glucocorticoid replacement in ACTH deficienct hypopituitary patients by studying different commonly used dose regimes of hydrocortisone replacement. The regimes range from 10mg to 30mg daily and we will assess the integrated serum cortisol levels, tissue cortisol exposure, metabolic and vascular sequelae of each regimen. We seek that whic most closely resembles the metabolic profile of our healthy control subjects. |
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E.2.2 | Secondary objectives of the trial |
To assess the side effects of over or under replacement of hydrocortisone in the hypopituitary patient. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male, Age >18 years Hypopituitarism Known severe ACTH deficiency as defined by a basal serum cortisol <100nmol/l and failure of a stimulation test. |
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E.4 | Principal exclusion criteria |
Female Age <18 years Patients with acute medical or surgical illness Advanced cardiac or pulmonary disease Unstable Angina/MI in the preceeding 3 months Patients with a terminal illness Patients on steroids for reasons other than ACTH deficiency Patients on phenytoin or other agents that interfere with corticosteroid metabolism. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The identification of a dose of hydrocortisone which results in a metabolic profile that most closely resembles that of the healthy control subjects. |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Healthy subjects not given hydrocortisone will be studied |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Healthy control subjects not given hydrocortisone |
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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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |