Effect of Mycophenolate Mofetil in presence of antacids
Not Applicable
- Conditions
- Health Condition 1: M349- Systemic sclerosis, unspecified
- Registration Number
- CTRI/2020/06/025939
- Lead Sponsor
- Centre for Arthritis and Rheumatism Excellence CARE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Scleroderma diagnosed with ACR criteria
Scleroderma patients on a stable dose of MMF for more than 2 months ( 1.5- 3 gm/day )
Exclusion Criteria
Co medication with cholestyramine, magnesium or aluminium containing antacids and rifampicin
Patients on high dose of corticoteroids( >.5mg/kg)
GFR < 30ml/min
HIV HCV, HBV â?? Positive
End stage lung disease
Those who have documented Gastro duodenal ulce
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess whether esomeprazole and ranitidine have any effect on the bioavailability of MMF in scleroderma patients. <br/ ><br> <br/ ><br> To assess whether the Anti-acid medications have any effect on immunosuppressive effect of MMF in scleroderma patients by monitoring IMPDH activity . <br/ ><br> <br/ ><br> To assess the effectiveness of esomeprazole and ranitidine in preventing mycophenolate induced gastrointestinal side effects in scleroderma patients <br/ ><br>Â <br/ ><br>Timepoint: every 4 weeks
- Secondary Outcome Measures
Name Time Method ATimepoint: NA