NCT01326845

Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study

A Multicenter, Randomized, Comparative Study of Different Deferasirox Administration Regimens on Gastrointestinal (GI) Tolerability in Low or Intermediate (Int-1) Risk MDS Myelodysplastic Syndrome Patients With Transfusional Iron Overload.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens. The patient population consists of low or intermediate (int-1) risk myelodysplastic syndrome (MDS) patients with transfusional iron overload. The study patients are randomized to either a morning dose of 20 mg/kg/day deferasirox or an evening dose of the same. Patients are then followed up for 6 months for any GI events and are assessed using patient reported outcomes tools e.g. a patient diary.

Conditions

• Myelodysplastic Syndrome
• Transfusional Iron Overload

Interventions

Type	Name	Description
DRUG	Deferasirox

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-03-31
• Last updated: 2017-03-03
• Results posted: 2013-11-15

Locations

10 sites across 4 countries: France, Italy, South Africa, Spain