NCT01011322

A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Lipid Therapeutics GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The participation in this clinical study will last approximately 21 weeks with a 1 week screening period and a 12 weeks treatment duration. If the study doctor finds, that the patients disease has significantly improved he/she will enter a treatment free follow-up period of 8 weeks. In total the study consists of 5 to 6 clinical visits (V1 - V6) and 1 telephone follow-up call.

Conditions

• Ulcerative Colitis
• Large Intestine
• Diarrhea
• Abdominal Pain

Interventions

Type	Name	Description
DRUG	LT-02	Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks
DRUG	placebo	placebo

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-07-01
• Completion: 2012-02-01
• First posted: 2009-11-11
• Last updated: 2011-11-16

Locations

26 sites across 3 countries: Germany, Lithuania, Romania