Trial | NCT01011322  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    156
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.
Study Started
Dec 31
2009
Primary Completion
Jul 31
2011
Study Completion
Feb 29
2012
Anticipated
Last Update
Nov 16
2011
Estimate

Drug LT-02

Comparison of different dosages of drug versus placebo. 4 times daily over 12 weeks

Drug placebo

placebo

LT-02 Dose 1 Experimental

0.2g IMP per dose

LT-02 Dose 2 Experimental

0.4g IMP per dose

LT-02 Dose 3 Experimental

0.8g IMP per dose

Sugar pill Placebo Comparator

placebo matching to 0g of IMP,

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
No Results Posted