NCT00417690终止2 期
A Prospective Randomized Double-Blind Study of PASER® in the Management of Patients Experiencing an Acute Flare of Crohn's Disease
Jacobus Pharmaceutical5 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
研究概览
简要总结
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Crohn's disease involving predominantly the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
- •Harvey Bradshaw Index of at least 7
- •The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
- •Written informed consent
排除标准
- •Concomitant corticosteroids, including budesonide
- •Corticosteroids within the previous 2 months
- •Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
- •Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
- •Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
- •If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
- •Current experimental drugs or experimental drugs within the last 3 months
- •If the severity of the flare has started to decrease spontaneously
- •Coexisting diagnosis of primary sclerosing cholangitis,
- •Infectious diarrhea,
- •Signs of intestinal obstruction or perforation or abscess,
- •New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
- •Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
- •Allergy or sensitivity to salicylates
- •Pregnancy or breast-feeding
- •Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
- •Severe renal or hepatic disease
研究组 & 干预措施
A
Experimental
Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
干预措施: 4-Aminosalicylic acid (Drug)
P
Placebo Comparator
One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks
干预措施: PASER placebo granules (Drug)
结局指标
主要结局
Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline
时间窗: 4 weeks
次要结局
- Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks(4 weeks)
- Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks(4 weeks)
- Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks(4 weeks)
- Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary(up to 4 weeks)
- Increase in IBDQ to greater than 170 and the time to score above 170(4 weeks)
- The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary(up to 4 weeks)
- Absence of night time stools, if they were present on entry, and time to disappearance(up to 4 weeks)
- Time to normalization of all other components in the diary(up to 4 weeks)
- Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization(2 weeks and 4 weeks)
- Change in global physician assessment of disease activity from baseline to study completion(4 weeks)
研究者
研究点 (5)
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