Cystinuria MedDRA version: 14.1 Level: PT Classification code 10011778 Term: Cystinuria System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Paracetamol tablets B.P. 500mg
Product Name: Paracetamol Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Conc
Sponsors
Royal Liverpool And Broadgreen University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with cystinuria Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Under 18 years old 2. Unable to give consent 3. Drinks alcohol regularly over the recommended limit 4. History of liver disease 5. History of paracetamol hypersensitivities 6. History of psychiatric disorder or self harm 7. Patiets who are likely to be glutathione deplete (e.g. patients with history of cystic fibrosis, HIV infection, starvation, cachexia) 8. Patient taking other drugs containing paracetamol regularly 9. Patients taking long term liver enzyme inducer drugs (e.g. carbamazepine, phenobarbital, phenytoin, primidone, rifampicin and St John’s Wort) 10. Pregnancy 11. Patients on another study in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does paracetamol reduce the amount urinary cystine excreted in patients with cystinuria?;Secondary Objective: 1.Do different doses of paracetamol affect the amount of urinary cystine excreted in patients with cystinuria differently? 2.To observe any serious adverse events related to paracetamol during the study;Primary end point(s): The mean amount of 24-hour urinary cystine excretion.;Timepoint(s) of evaluation of this end point: 24-hour urinary samples taken during the week (two samples taken anythime between Day 3 to Day 7) when the patient is in either Paracetamol 2g/day, Paracetamol 4g/day or Control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The mean amount of 24-hour urinary paracetamol metabolite excretion (paracetamol-cysteine, paracetamol mercapturate, paracetamol-sulphate and paracetamol-gluconate conjugates);Timepoint(s) of evaluation of this end point: 24-hour urinary samples taken during the week (two samples taken anythime between Day 3 to Day 7) when the patient is in either Paracetamol 2g/day, Paracetamol 4g/day or Control groups. | — |
Countries
United Kingdom
Outcome results
None listed