E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Normal, healthy volunteers to establish a reference range for the synacthen test, plus patients with hypoadrenalism/hypopituitarism |
|
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 | 10020936 |
E.1.2 | Term | Hypoadrenalism |
|
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 |
|
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 |
To define the cortisol response to Synacthen in normal volunteers using commercially available cortisol immunoassays in use in clinical laboratories in the UK |
|
E.2.2 | Secondary objectives of the trial |
To compare cortisol results against the gold standard method gas chromatography - mass spectrometry To investigate the effect of oral contraceptives containing ethinyloestradiol on the cortisol cut-off in response to Synacthen To define the salivary cortisol response to Synacthen in normal volunteers To define the 17OHP response to Synacthen in normal female volunteers |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In self-proclaimed good health Free of illness on the day of testing Not taking drug therapy (other than females under the age of 40 years who are permitted to be taking an ethinyloestradiol-containing oral contraceptive) |
|
E.4 | Principal exclusion criteria |
Pregnancy. Females of childbearing potential must have a negative pregnancy test before enrolment Lactation/breastfeeding Taking corticosteroids currently Significant intercurrent illness History of thyroid or other autoimmune disease Previous history of hypersensitivity to Synacthen Previous history of asthma Any mental condition rendering the patient unable to understand the nature or possible consequences of the study, and/or evidence of an uncooperative attitude |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To establish method-dependent cortisol cut-offs for the normal response to Synacthen using the 5th percentile |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | Information not present in EudraCT |
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 | 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 | 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
| 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
|
Last visit of the last subject |
|
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 |