EUCTR2005-002319-26-BE进行中（未招募）不适用
Efficacy and safety of AZD9056 200 mg once daily versus placebo in adult patients with active Crohn’s disease – A randomized, double-blind, four week, parallel-group, multicentre, phase II study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •For inclusion in the study s must fulfil all of the following criteria:
- •1. Provision of written informed consent
- •2. Female or male =18 years of age. Female patients should have cessation of regular
- •menses for more than 12 months, be surgically sterile, or using two forms of
- •contraceptives throughout the study period.
- •3. Diagnosis of Crohn’s disease affecting ileum and/or colon verified by X-ray (small
- •bowel follow-through) and/or endoscopy
- •4. Disease activity defined as CDAI =220
- •5. Normal stool culture
- •6. Normal values of aspartate aminotransferase (ASAT), alanine aminotransferase
- •(ALAT), alkaline phosphatase (ALP), and bilirubin
- •7. If treated with oral sulphasalazine, olsalazine or 5-ASA at entry, the dose should
- •have been kept constant during two weeks prior to visit 2
- •The patients will not be excluded from other aspects of the study described in this Clinical Study
- •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
- •Any of the following is regarded as a criterion for exclusion from the study:
- •1. Any significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal
- •(other than Crohn’s disease), liver, renal, neurological, musculoskeletal,
- •endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
- •in the opinion of the investigator, may either put the patient at risk because of
- •participation in the study, or may influence the results of the study or patient´s
- •ability to participate in the study
- •2. Ileostomy or ileo-pouch-anal anastomosis
- •3. Active listeriosis or tuberculosis or positive screening for tuberculosis or a major
- •episode of infection (e.g. pneumonia, pyelonephritis) requiring hospitalisation or
- •treatment with intravenous antibiotics within 6 months or oral antibiotics within 2
- •months prior to visit 2
- •4. Septic complication, abscess, perforation, obstruction and/or fistulae, except
- •for inactive perianal fistulae
- •5. Need for immediate surgery or unlikely to complete the trial due to poor general
- •6. Histologically documented gastrointestinal malignancy or high-grade dysplasia
- •within the last five years prior to visit 1
- •7. History of carcinoma (excluding basal and squamous skin cell carcinoma) within
- •the last five years prior to visit 1
- •8. Uncontrolled diabetes
- •9. Verified active gastric or duodenal ulcer
- •10. Rheumatoid arthritis
- •11. Sclerosing cholangitis
- •12. Clinically significant abnormal values for White blood cells (WBC), neutrophils
- •or platelet in the opinion of the investigator
- •13. Requirement for non-steroid anti-inflammatory drugs (NSAIDs) for chronic use
- •except low dose aminosalicylic acid, ASA (<350 mg daily) for prophylaxis
- •14. Concomitant disease which requires glucocorticosteroid treatment
- •15. Reception of infliximab or cyclosporine within 12 weeks prior to visit 2
- •16. Reception of any kind of experimental treatment (e.g. cytokines, probiotics, or
- •helminthics) within 12 weeks prior to visit 2
- •17. Reception of immunization with live viruses (e.g. polio) or live bacteria (e.g.
- •tubercle bacilli) within 12 weeks prior to visit 2
- •18. Known HIV or belonging to group with high risk for HIV infection
- •19. Clinically abnormal ECG, current treatment with antiarrhythmic drugs, history
- •of clinically significant cardiac arrythmias, or resting QTc (according to Bazett’s
- •correction method) greater than 460 ms on more than two baseline ECGs
- •20. Evidence of retinopathy on fundoscopic examination
- •21. Participation in any clinical study involving an investigational product within 90
- •days prior to randomization
- •22. Previous randomization in the present study
- •23. Alcohol or drug abuse or any other conditions associated with poor compliance
- •or other reason for not being appropriate for the study, in the opinion of the
- •investigator
- •24. History of known hypersensitivity to the excepients unse in the study
- •investigational product e.g. lactose.
研究者
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