EUCTR2008-007952-90-LT进行中（未招募）不适用
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 个研究点目标入组 144 人开始时间: 2009年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •infectious colitis [microbiological testing, including Clostridium difficile toxin A
- •and B, Campylobacter spp., E. coli 0157:H7; depending on the medical
- •history fresh, warm stool samples should be tested for amoebae or other
- •parasites], exclusion of drug-induced forms of colitis,
- •b) Endoscopic features, including a colonoscopy with intubation of the
- •terminal ileum: inflammation of the rectum, continuous inflammation to more
- •proximal parts, usually clear demarcation between inflamed and normal
- •areas. Signs of inflammation are vascular congestion or reduction of visible
- •vascular patterns, as well as mucosal friability [after contact with the
- •endoscope]. Moreover, a coarse granular appearance, mucosal erosions or
- •ulcerations may occur,
- •c) Histologic features from multiple mucosal biopsies: absence of
- •granulomas, architectural features [crypt branching, crypt distortion, crypt
- •atrophy or surface irregularity], epithelial cell abnormalities [mucin depletion,
- •Paneth cell metaplasia] and inflammatory signs [increased lamina propria
- •cellularity, basal plasmacytosis, basal lymphoid aggregates, lamina propria
- •eosinophils],
- •Patients may be included into the study if clinician, endoscopist [may be
- •identical with clinician] and pathologist state that the found features are
- •compatible with the diagnosis of UC),
- •3) Patients naïve to any form of controlled release PC treatment,
- •4) Active disease course for the last 6 weeks or longer with bloody diarrhea
- •(anamnestic mean number of bloody stool per day =4),
- •5) SCCAI =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit (V2),
- •(SCCAI and subscore for blood are calculated as the rounded mean over the
- •last 7 days),
- •6) Patients with an inadequate response to a treatment with =3g of mesalazine
- •per day, over a period of 4 weeks or a documented intolerance to
- •mesalazine,
- •7) Other drugs for the treatment of UC are allowed, under the following
- •circumstances:
- •- Systemic acting oral steroids are allowed if taken for =8 weeks prior to start
- •of the study with a stable dose for =4 weeks prior to start of the study,
- •- Immunosuppressive therapy with azathioprine (2-2.5 mg/kg) or 6-
- •mercaptopurine (1-1.5 mg/kg) is allowed, if taken for =3 months prior to
- •start of the study,
- •8) Ability of the patient to understand character and individual consequences of
- •the clinical study,
- •9) Special requirements for women of childbearing potential:
- •- Negative pregnancy test at V1 and V2,
- 另有 1 项未显示
排除标准
- •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
- •prior to study start,
- •6) Treatment with other IMP within 3 months prior to study entry,
- •7) Condition after complete or partial resection of the colon,
- •8) Infectious colitis, including cytomegalovirus or Clostridium difficile induced
- •9) Crohn’s disease,
- •10) Colitis due to other reasons than UC like known diverticulitis, radiation colitis,
- •ischemic colitis, microscopic colitis, or indeterminate colitis,
- •11) Malabsorption syndromes, chronic pancreatitis,
- •12) Celiac disease,
- •13) Acute bleeding hemorrhoids,
- •14) Other inflammatory or bleeding disorders of the gastrointestinal tract, or
- •diseases that may cause diarrhea or gastrointestinal bleeding,
- •15) Pregnant or nursing women,
- •16) Known drug, alcohol, or medication abuse during the last 2 years prior to
- •start of the study,
- •17) Any other uncontrolled systemic diseases (e.g. cardiac, renal, pulmonary, or
- •hepatic) or severe chronic diseases (e.g. malignant tumor, HIV infection,
- •high-grade intraepithelial neoplasia),
- •18) Ulcerative proctitis with a disease extent <10 cm,
- •19) Participation in another clinical trial within the last 30 days, simultaneous
- •participation in another clinical trial, or previous participation in this trial.
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