drugset / Trial / NCT01567956

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

NCT01567956

Phase 3 Terminated 150 enrolled sigma-tau i.f.r. S.p.A. PRA Health Sciences · collab
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
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject LEVOCARNITINE PROPIONATE Small molecule 500 mg

Indications