A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.

ipid Therapeutics GmbH0 sites144 target enrollmentStarted: September 15, 2009Last updated: March 19, 2012

Overview

No summary available.

•1\) Men and women \=18 years who have given written Informed Consent,
•2\) Patients with proven UC (according to ECCO consensus definition \[28]:
•UC is a chronic continuous mucosal inflammation of the colon without
•granulomas on biopsy, affecting the rectum and variable extent of the colon
•in continuity, which is characterized by a relapsing and remitting course. The
•diagnoses should be established by a combination of medical history, clinical
•evalution, and typical endoscopic and histologic findings:
•a) Medical history and clinical features: loose stools \[\>6 weeks], episodes of
•bloody stools and stool urgency, episodes of relapse and periods of
•remission or an unremitting, continuous course over months; exclusion of

•1\) Toxic megacolon or fulminant colitis,
•2\) No current treatment for UC with either highdose 5\-ASA (at least 3g/d) or oral steroids or immunosuppressants or combinations
•3\) Concomitant therapy as following:
•a) Therapy with cyclosporine, tacrolimus, methotrexate, or tumor necrosis\-
•(TNF)\-alpha\-antagonists within 3 months prior to study entry,
•b) Current treatment with opiates or loperamide,
•c) Current antibiotic treatment,
•4\) Rectal applications of aminosalicylates, budesonide, or other steroids within
•4 weeks prior to study entry,
•5\) Oral application of topically acting steroids, e.g. budesonide, within 4 weeks

Sponsor

ipid Therapeutics GmbH