Paracetamol in Treatment of Cystinuria

Conditions: Cystinuria
MedDRA version: 14.1Level: PTClassification code 10011778Term: CystinuriaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-002466-20-GB

Lead Sponsor: Royal Liverpool And Broadgreen University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?<br>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 Outcome Measures

Name	Time	Method
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.