EUCTR2008-007952-90-DE
Active, not recruiting
Not Applicable
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. - Amendment No. 3 (Version 1.0), 16-JUL-2010
ipid Therapeutics GmbH0 sites240 target enrollmentStarted: August 4, 2009Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ipid Therapeutics GmbH
- Enrollment
- 240
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\) Men and women \=18 years who have given written Informed Consent,
- •2\) Patients with proven UC (according to ECCO consensus definition \[24]:
- •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
Exclusion Criteria
- •1\) Toxic megacolon or fulminant colitis,
- •2\) 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,
- •3\) Rectal applications of aminosalicylates, budesonide, or other steroids within
- •4 weeks prior to study entry,
- •4\) Oral application of topically acting steroids, e.g. budesonide, within 4 weeks
- •prior to study start,
- •5\) Treatment with other IMP within 3 months prior to study entry,
Investigators
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