Status:
COMPLETED
Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test
Lead Sponsor:
Cardiff University
Conditions:
Healthy
Adrenal Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Objectives: To establish valid serum total cortisol and salivary cut-offs for use with the short Synacthen test in patients with normal CBG concentrations. To investigate, using current assays, the ...
Detailed Description
Synacthen® is a synthetic analogue of ACTH which has been used since the 1960s to assess adrenal sufficiency. It is now well established as a first line test to investigate diseases of the hypothalamo...
Eligibility Criteria
Inclusion
- Volunteers will be in self-proclaimed good health
- Volunteers will be free of illness on the day of testing
- Volunteers will not be taking drug therapy.
- Patients will be free of intercurrent illness on the day of testing
- Patients will have a confirmed diagnosis of hypoadrenalism or hypopituitarism
Exclusion
- Is pregnant or lactating. Females of childbearing potential must have a negative pregnancy test before enrollment onto the study. Non-child bearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
- Is using corticosteroids,
- has any significant intercurrent disease,
- has a history of thyroid or other autoimmune disease,
- has a previous history of hypersensitivity to Synacthen®,
- has a previous history of asthma
- has a history of allergic disorder
- has any mental condition rendering the patient unable to understand the nature or possible consequences of the study, and/or evidence of an uncooperative attitude.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2013
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00851942
Start Date
September 1 2008
End Date
January 31 2013
Last Update
August 12 2020
Active Locations (1)
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1
Clinical Research Facility, University Hospital of Wales
Cardiff, South Glamorgan, United Kingdom, CF14 4XW