EUCTR2009-011608-51-SE进行中（未招募）不适用
A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 60 人开始时间: 2009年6月22日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Male or female of non-childbearing potential, 18 years of age or older at the time of signing the informed consent.
- •- Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneuos amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 MIU/ml and estradiol < 40 pg/ml (<140pmol/L) is confirmatory].
- •2. Presence of mild-to-moderately active ulcerative colitis spread beyond the rectum (inflammation extending = 15 cm from anal verge) as evidenced by clinical signs and endoscopy.
- •3. UDCAI score 4-10 (inclusive) with rectal bleeding score = 1, endoscopy score = 1 and Physician’s rating of disease activity < 3.
- •4. Body weight =50 kg and BMI within the range 18.5-34.9 kg/m2 (inclusive).
- •5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •1. History of sensitivity to aminosalicylates, macrolides, coricosteroids or any component of study medications, history of hypersensitivity to ACTH, SYNACTHEN or SYNACTHEN DEPOT, or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates patient’s participation in the study.
- •2. History of renal sensitivity to 5-ASA or presence of nephritis, nephropathia or renal function impairment, as evidenced by any of the following: serum creatinine >130 µmol/L, 2+ proteinuria on dipstick urinalysis, or presence of casts (red cell casts, white cell casts or epithelial cell casts) in urine sediment.
- •3. Presence or a history of asthma or presence or history of other serious allergic disorder that, in the opinion of the Investigator, increases the risk of allergic reaction to SYNACTHEN.
- •4. Presence or history of chronic liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) as evidenced by medical history or by AST and ALT = 2xULN, alkaline phosphatase and bilirubin > 1.5xULN.
- •5. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •6. Presence of significant hematologic disorder as evidenced by neutrophil count <1.5x109/L, platelet count <150x109/L, or significant bleeding or immune system disorder.
- •7. QTcB or QTcF >450 msec; or QTc >480 msec in patients with Bundle Branch Block, based on an average QTc value of triplicate ECGs, if the first ECG showed an abnormal value.
- •8. Presence of a significant cardiac, pulmonary, metabolic or infectious disease or mental disorder that, in the opinion of the Investigator, represents an unacceptable safety risk for participation in this trial.
- •9. History of malignant neoplastic disease within the past 5 years other than localized basal cell skin cancer, squamous cell skin cancer or cancer in situ that has been resected.
- •10. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks (one drink is equivalent to 12 ounces [360 mL] of beer, 5 ounces [150 mL] of wine or 1.5 ounces [45 mL] of 80 proof distilled spirits AND a history or presence of recreational drug abuse or dependence.
- •11. Presence of infectious colitis as evidenced by stool culture positive for enteric pathogens or positive Clostridium difficile cytotoxin assay.
- •12. Suspicion of Crohn’s disease, indeterminate colitis, microscopic colitis, ischaemic colitis or radiation-induced colitis, based on medical history, endoscopy and/or histological findings.
- •13. Bowel surgery within last 12 months.
- •14. Treatment with oral aminosalicylates at dose = 3 g/day or dose modification (except a transient shift lasting up to 3 days) within 4 weeks prior to Day 1 visit or treatment with topical aminosalicylates at any dose within 4 weeks prior to Day 1 visit.
- •15. Treatment with systemic or topical corticosteroids within 4 weeks prior to Day 1 visit.
- •16. Treatment with TNF-a inhibitors or other biologics within 2 months prior to Day 1 visit.
- •17. Treatment with immunosuppressants (azathioprine or 6-mercaptopurine), if initiated within 3 months prior to Day 1 visit, or if changed in terms of drug or dose within 3 months prior to Day 1 visit.
- •18. Regular use of probiotic or prebiotic preparations, if initiated within 4 weeks pr
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