drugset / Trial / NCT01538251

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

NCT01538251

Phase 3 Terminated 147 enrolled sigma-tau i.f.r. S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of the trial is to test safety, tolerability and efficacy of Propionyl-L-carnitine modified release tablets 1g/die in reducing the symptoms of the disease with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment. It will also aim to investigate capability of the treatment in the maintenance of remission after four weeks of treatment interruption; histological changes will be also evaluated and finally, improvement in the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)will be investigated.

Timeline

Start
2012-04
Primary completion
2013-10
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject LEVOCARNITINE PROPIONATE Small molecule 500 mg Oral

Indications