NCT01026857

Propionyl-L-Carnitine in Ulcerative Colitis

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: sigma-tau i.f.r. S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Propionyl-L-carnitine administration may ameliorate the illness in patients affected by mild to moderate ulcerative colitis already in treatment with one of the standard treatments (corticosteroids excluded).

Detailed description

The trial foresees the administration of 2 different dosages of Propionyl-L-carnitine (ST261) colon release tablets, 1 g/die and 2 g/die. The primary objective of this trial is to evaluate the clinical/endoscopic response defined as a lowering of the Disease Activity Index (DAI score) of at least 3 points ot the reaching of remission, the clinical/endoscopic remission (DAI score \<= 2 with no individual subscore \> 1) and histological efficacy of the two combined dosages of PLC (i.e. PLC 1 g/die + 2 g/die) in comparison to placebo, defined as an improvement of the Histological Index (HI) of at least 1 point at the end of the study (a final HI score of \<= 1 will be defined as an histological remission). The secondary objective is to evaluate the clinical/endoscopic and histological efficacy of the two dosages of PLC individually considered in comparison to Placebo, in order to gather information on the dosage to be used in subsequent trials. The safety and tolerability of the regimens studied will also be objectives of the study.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Propionyl-L-Carnitine	PLC colon release tablet 1 g/die for 4 weeks
DRUG	Propionyl-L-Carnitine	PLC colon release tablet 2 g/die for 4 weeks
DRUG	Placebo	Placebo PLC colon release tablet 2 g/die for 4 weeks

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-04-01
• Completion: 2009-12-01
• First posted: 2009-12-07
• Last updated: 2017-06-15

Locations

15 sites across 4 countries: Italy, Lithuania, Poland, Russia