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Trial · Interventional

CompletedPhase 4Registry data

Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test

NCTNCT00851942 (opens ClinicalTrials.gov in a new tab)Other idSPON 431-07
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
165 participants (actual)
Sponsor
Cardiff University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
Sept 2008
Primary completion
28 Jul 2012
Completion
31 Jan 2013
First posted
26 Feb 2009 (estimated)
Last update posted
12 Aug 2020
Conditions
Healthy · Adrenal Insufficiency · Hypopituitarism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2008200920102011201220132014
  1. Ph 4

    Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test

    NCT00851942

    Sept 2008 to 31 Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 effect of assay differences on the serum total cortisol cut-off. To explore the performance of these cut-offs in groups of patients with suspected adrenal insufficiency and high and low serum CBG concentration. Methodology: An ACTH test (250 micrograms iv ACTH1-24) will be undertaken in healthy volunteers, women taking an oestrogen-containing oral contraceptive pill (OCP), patients with adrenal insufficiency and patients with low serum albumin. Serum cortisol in the samples collected from healthy volunteers will be measured using GC-MS, Advia Centaur (Siemens), Architect (Abbott), Modular Analytics E170 (Roche), Immulite 2000 (Siemens) and Access (Beckman) automated immunoassays. The estimated lower reference limit for the 30 min cortisol response to ACTH, defined as the 2.5th percentile of log-transformed concentrations, will be determined in this healthy population and used as a cut-off in the patient groups studied.

Interventions

  • Synacthen (Tetracosactrin)Drug

Arms1

  • Experimental

    Synacthen 250 micrograms

    IV injection of 250 micrograms of Synacthen in 1m

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The primary end-point of the study will be to establish method dependent cortisol cut offs for the normal response to Synacthen® using the 5th percentile.

    Time frame · Cortisol response at 30 minutes

Secondary outcomes(4)

  1. Cortisol measurements by immunoassay will be compared with the GC-MS gold standard method for normal volunteers and patients with hypopituitarism and hypoadrenalism.

    Time frame · Cortisol response at 30 minutes

  2. Synacthen® responses in women taking ethinyloestradiol-containing contraceptive pills will be compared with those who are not.

    Time frame · Cortisol response at 30 minutes

  3. We will establish cut offs for the salivary cortisol response to Synacthen® in normal volunteers using the 5th percentile.

    Time frame · Cortisol response at 30 minutes

  4. We will establish a 17OHP cut off in response to Synacthen® in normal female volunteers using the 5th percentile.

    Time frame · 17OHP response at 60 minutes

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedOwen LJ, Adaway JE, Davies S, Neale S, El-Farhan N, Ducroq D, Evans C, Rees DA, MacKenzie F, Keevil BG. Development of a rapid assay for the analysis of serum cortisol and its implementation into a routine service laboratory. Ann Clin Biochem. 2013 Jul;50(Pt 4):345-52. doi: 10.1177/0004563212473448. Epub 2013 Jun 12. PMID 23761380

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Criteria: * 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.

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