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

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lipid Therapeutics GmbH

Criteria

Inclusion Criteria:

• Men and women 18 years or older who have given written Informed Consent

• Patients with proven ulcerative colitis

• Active disease course for the last 6 weeks or longer with bloody diarrhea

• Patients with an inadequate response to a treatment with mesalazine or a documented intolerance to mesalazine.

Exclusion Criteria:

• Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,

• Crohn's disease,

• Colitis due to other reasons than ulcerative colitis like known diverticulitis, radiation colitis, ischemic colitis, microscopic colitis, or indeterminate colitis,

• Treatment with other investigational medicinal product within 3 months prior to study entry