Health Condition 1: M349- Systemic sclerosis, unspecified
Conditions
Interventions
Intervention1: Mycophenolic acid (MMF)
Esomeprazole
ranitidine
: Comparative study on the effect of Esomeprazole and Ranitidine on the bioavailability and efficacy of MMF in Scleroderma patients.
I
Sponsors
Centre for Arthritis and Rheumatism Excellence CARE
Eligibility
Inclusion criteria
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
Exclusion criteria: Co medication with cholestyramine, magnesium or aluminium containing antacids and rifampicin Patients on high dose of corticoteroids( >.5mg/kg) GFR HIV HCV, HBV â?? Positive End stage lung disease Those who have documented Gastro duodenal ulce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether esomeprazole and ranitidine have any effect on the bioavailability of MMF in scleroderma patients. To assess whether the Anti-acid medications have any effect on immunosuppressive effect of MMF in scleroderma patients by monitoring IMPDH activity . To assess the effectiveness of esomeprazole and ranitidine in preventing mycophenolate induced gastrointestinal side effects in scleroderma patients  Timepoint: every 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Padmanabha Shenoy
Centre for Arthritis and Rheumatism Excellence( CARE)
Outcome results
None listed