THERAPEUTIC EFFECTIIVENESS OF N-ACETYL-CYSTEINE AND ASCORBIC ACID IN PATIENTS WITH ALKAPTONURIA-OCHRONOSIS - Acetilcisteina-Ocronosi-SI/2009
- Conditions
- patient affected by alkaptonuria-ocronosis
- Registration Number
- EUCTR2009-012707-26-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria:
- informed consent
- Established diagnosis of alkaptonuria
- Age:18-75
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria
- NAC intolerance
- History of malignacy or neoplastic disease
- pregnant or lactanting females
- chronic or acute renal disease
- values of aspartate aminotrasferase (AST), alanine aminotrasferase (ALT) or bilirubin > 2 x upper limit of normal (ULN)
-history of excessive alcohol consuption or chronic alcohol induced disease
-patients who were treated with ascorbic acid or other antioxidant agents in the previous 30 days
- disorders that may interfere with the interpretation of the outcome data
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of NAC effectiveness to inhibit HGA oxidation and its polymerization within connective tissue in patients affected by Ochronosis;Secondary Objective: Evaluation of NAC treatment on 1)plasmatic and urinary parameters of oxidative stress 2) radiologic assessment of joint damage;Primary end point(s): Evaluation of NAC effect on plasmatic and urinary levels of homogentisic acid in <br>patients with homogentisic acid oxidase (HGO) deficiency.
- Secondary Outcome Measures
Name Time Method