NCT00613197已完成3 期
A One Year, Multi-center, Randomised, Double-blind Placebo-controlled Parallel-groups Assessment of the Tolerability, Safety and Efficacy of Epanova Soft Gelatin Capsules 4g/Day for Maintenance of Remission of Crohn's Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- time to clinical relapse
研究概览
简要总结
The primary objective of this study is to assess the ability of EpanovaTM Soft Gelatin Capsules at a total daily dose of 4g (4x 1g capsules) to maintain remission (Crohn's Disease Activity Index CDAI < 150) in CD patients in whom remission, stable for at least three months and no longer than one year, has been induced by corticosteroids, azathioprine/6-MP, methotrexate, 5-ASA or antibiotics.
Secondary objectives are to assess the:
efficacy of Epanova versus placebo by Crohn's Disease Activity Index (CDAI), Investigator and Subject Global Ratings, employment status and use of CD related medical visits in subjects with CD in remission
safety and tolerability of Epanova
ability of Epanova to maintain the quality of life of CD patients in remission
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject, age 17 or older; country-specific age limitations will be followed
- •Diagnosis of Crohn's disease confirmed by radiological studies or endoscopy or surgical pathology within 36 months prior to randomisation
- •In remission for at least 3 months, but no longer than 12 months; remission being defined as meeting both of the two conditions: (1) clinically in remission with a CDAI of less than 150 and (2) off steroids and/or immunosuppressants for at least 3 months, if remission had been induced with such medications
排除标准
- •Intolerance of omega-3 fatty acids or known allergy to fish or fish products
- •Ongoing CD therapy with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, tube feeding, defined formula diets or parenteral nutrition
- •In 3 months prior to randomisation received: systemic steroid therapy, azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, probiotic products or preparations containing fish oil
- •In 12 months prior to randomisation received: biologicals e.g. enbrel, infliximab, mycophenolate, tacrolimus, thalidomide, other immune modifiers and/or investigational products
- •Chronic use of narcotics for pain control (opiates for diarrhoea are acceptable)
- •Documented short bowel syndrome, ostomy
- •Need for bowel surgery for CD, bowel obstruction or resection in past 3 months (a subject who had a bowel resection in the past must have had at least one relapse after the surgery)
- •Malignancy and/or clinically significant impairment in cardiac, liver or renal function, CNS, pulmonary, hematological, immunological, vascular and gastrointestinal disease in addition to CD
- •Known alcoholism or drug abuse
- •Any medical conditions which, in the investigator's opinion, may interfere with the evaluation of the trial medication
- •Any of the following laboratory abnormalities:
- •White blood count < 3 x 109/L
- •Lymphocyte count < 0.5 x 109/L
- •Haemoglobin < 80 g/L
- •Platelet count < 125 x 109/L or > 800 x 109/L
- •ALT or AST > 2.0 times the upper limit of normal
- •Alkaline Phosphatase > 2.0 times the upper limit of normal
- •Serum Creatinine > 1.5 times the upper limit of normal
研究组 & 干预措施
1 Epanova
Experimental
干预措施: Epanova (Drug)
2 Placebo
Placebo Comparator
干预措施: Epanova (Drug)
结局指标
主要结局
time to clinical relapse
时间窗: 52 weeks
次要结局
- CDAI Investigator and subject global rating Quality of life C-reactive protein(52 weeks)
研究者
研究点 (1)
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