Adrenocortical carcinoma · ISRCTN67193733
The Pulses Study
Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia
- Status
- recruitment ended 2017-08-14 (ISRCTN)
- Phase
- Not Applicable
- Sponsor
- Not stated
- Registry records
- ISRCTN ISRCTN67193733 (recruitment ended 2017-08-14)Registry last updated 2023-10-20
Eligibility, line by line
Inclusion criteria: 1. Male and female patients with confirmed Addison’s disease and CAH 2. Aged 18 to 64 years 3. Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active 4. Right handed 5. Able to give informed consent Exclusion criteria: 1. Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances. 2. No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids 3. Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin) 4. Diagnosis of Addison’s disease less than 6 months ago 5. Pregnant or lactating women 6. Greater than 21 units of alcohol per week 7. Taking of any investigational drug within the past two months 8. Known allergy to any of the study medications and /or materials used in the pump 9. Needle phobia 10. Contraindication to fMRI scan i.e. metal implant/shrapnel 11. Claustrophobia 12. Left handed/significant ambidexterity 13. Dyslexia
Full eligibility text as the registry publishes it
Inclusion criteria: 1. Male and female patients with confirmed Addison’s disease and CAH 2. Aged 18 to 64 years 3. Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active 4. Right handed 5. Able to give informed consent Exclusion criteria: 1. Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances. 2. No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids 3. Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin) 4. Diagnosis of Addison’s disease less than 6 months ago 5. Pregnant or lactating women 6. Greater than 21 units of alcohol per week 7. Taking of any investigational drug within the past two months 8. Known allergy to any of the study medications and /or materials used in the pump 9. Needle phobia 10. Contraindication to fMRI scan i.e. metal implant/shrapnel 11. Claustrophobia 12. Left handed/significant ambidexterity 13. Dyslexia
Routes in: how this trial is reached and paid for
UK access: residence, not citizenship
Being a British citizen does not by itself entitle you to free NHS treatment; entitlement runs on being ordinarily resident in the UK.
The UK and EU agreed to continue a planned-treatment scheme equivalent to S2 from 1 January 2021, so an S2 issued by an EU insurer is the thing to ask about for a UK trial. Put the question to both your insurer and the trial coordinator, since sponsors sometimes cover trial-related care regardless.
Verify with: NHS: planned treatment abroad and the S2 route
Ask both; not free by citizenship
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Sites (1)
United Kingdom
- University of Bristol, Bristol