NL-OMON42465撤回3 期
Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - PCG-4/UCR
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for DB maintenance phase:
- •1. Signed informed consent,
- •2. Men or women, 18 to 70 years of age,
- •3. Historically confirmed diagnosis of UC by endoscopy and histology,
- •4. Patients being in remission at baseline,
- •5. Negative pregnancy test in females of childbearing potential at baseline visit,
- •6. Women of child-bearing potential have to apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly.
排除标准
- •Exclusion criteria for DB maintenance phase:
- •1. Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis), diverticular disease associated colitis,
- •2. Toxic megacolon or fulminant colitis,
- •3. Colon resection,
- •4. Malabsorption syndromes,
- •5. Celiac disease,
- •6. Bleeding hemorrhoids,
- •7. Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
- •8. History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack,
- •9. Any severe concomitant renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient*s compliance or the interpretation of the results,
- •10. Any relevant known systemic disease (e.g., AIDS, active tuberculosis),
- •11. Severe co-morbidity substantially reducing life expectancy,
- •12. History of cancer in the last five years,
- •13. Abnormal hepatic function at the screening visit), liver cirrhosis,
- •14. Abnormal renal function at the screening visit,
- •15. Either HbA1c *6.5% (*48 mmol/mol) at baseline visit, OR HbA1c >5.6% (38 mmol/mol) AND fasting blood glucose *100 mg/dl (*5.6 mmol/l) at baseline visit,
- •16. Patients with known hypersensitivity to soy,
- •17. Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP: LT-02 or mesalamine),
- •18. Treatment with steroids (oral, inhalative, or intravenous [IV]), cyclosporine or tacrolimus within last 4 weeks prior to randomization,
- •19. Treatment with methotrexate within last 6 weeks prior to randomization,
- •20. Treatment with TNF-alpha-antagonists, azathioprine, 6-mercaptopurine, or anti-integrin therapy within last 8 weeks prior to randomization,
- •21. Treatment with rectal mesalamine or corticosteroid formulations within last 2 weeks prior to randomization,
- •22. Treatment with other investigational drug within last 12 weeks prior to randomization except LT-02,
- •23. Concomitant treatment with coumarins (e.g., phenprocoumon),
- •24. Unwillingness to undergo endoscopy with biopsy sampling at end of treatment (EOT)/withdrawal visit of this study,
- •25. Clinical suspicion of addiction to alcohol or drugs,
- •26. Existing or intended pregnancy or breast-feeding,
- •27. Subjects deemed by the investigator to be unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study,
- •28. Participation in another clinical trial within the last 30 days prior to baseline visit (except for the Phase III study PCG-2/UCA), simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.
研究者
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