EUCTR2005-002319-26-HU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, pilot, 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 patients 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 at visit 2
- •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
- •8. If treated with azathioprine, methotrexate or 6-mercaptopurine at entry, the dose should have been kept constant for 3 months prior to Visit 2
- •9. For inclusion in the genetic component of the study, see Appendix C. If a patient decline to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, should they not consent to genetic sampling.
- •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, ileorectal anastomosis or proctocolectomy.
- •3. Active listeriosis or tuberculosis or positive screening for tuberculosis or a major
- •episode of infection (e.g. pneumonia, pyelonephritis) requiring hospitalisation within 3 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.Currently treated with glucocorticosteroids or stopped treatment with glucocorticosteroids less than 2 weeks prior to visit 2. However, nasal glucocorticosteroid sprays and/or low potent steroid ointment allowed.
- •15. Received of infliximab or cyclosporine within 12 weeks prior to visit 2
- •16. Received of any kind of experimental treatment (e.g. cytokines, probiotics, or
- •helminthics) within 12 weeks prior to visit 2
- •17. Received 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 at high risk for HIV infection
- •19. Clinically abnormal ECG, current treatment with antiarrhythmic drugs, history
- •of clinically significant cardiac arrythmias, or prolonged 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 used in the study
- •investigational product.
- •25. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
研究者
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