drugset / Trial / NCT00676221

Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)

NCT00676221

Phase 4 Unknown 110 enrolled Foothills Medical Centre Novartis · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the objectively measured GI symptom burden and improve GI-related quality of life. Primary Objective: To determine the incidence of GI-related symptoms and the health related quality of life of renal transplant patients that are currently tolerating MMF. Assessed by GSRS and GIQLI. Secondary Objective: To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.

Timeline

Start
2006-07
Primary completion
2008-08
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Sodium Unknown 720 mg Oral

Indications

No indication recorded.