The Safety of Celecoxib (Celebrex) in Patients With Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 28
- 主要终点
- Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
研究概览
简要总结
The investigators will select 60 people who are 18-70 years of age with Crohn's disease and randomly assign them to receive an 8-week trial of celecoxib and an 8-week trial of a placebo. There will be a 1-week interval or "wash-out" between trials when the participant does not take any study medication. The investigators will monitor the participants for 18 weeks after they start the medication and observe their Crohn's disease activity, assessing for flare-ups or exacerbations in the disease and other possible side effects of celecoxib. Based on these observations, a determination will be made by the investigators as to the safety of celecoxib. If celecoxib is found to be safe, then it may provide physicians with a medication that they can prescribe for people who have Crohn's disease and experience chronic pain from arthritis and arthralgia.
详细描述
Please refer to brief summary (above).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Greater than 18 years of age or less than 70 years of age
- •Confirmed diagnosis of Crohn's disease
- •Inactive disease (CDAI scores at baseline <150) or active disease (CDAI scores at baseline <200).
排除标准
- •Pregnant, nursing mothers and women of childbearing potential who are not using reliable contraception (i.e.: oral contraceptive pill [OCP], intrauterine device [IUD], Norplant)
- •Enrolled in any other study involving non-steroidal anti-inflammatory drug (NSAID) medications
- •NSAID use at time of study
- •Baseline moderate to severe Crohn's disease activity (CDAI > 200)
- •Current treatment of less than 6 months with mercaptopurine (6 MP) or immuran.
- •Treatment with current Crohn's medication for a period of less than 3 months
- •Surgery for Crohn's disease (within 1 month)
- •Known sensitivity to celecoxib, NSAIDs, or sulfonamides
- •History of gastritis, gastrointestinal bleeding, or peptic ulcer disease
- •Advanced kidney disease
- •Severe hepatic impairment
- •Subjects currently taking angiotensin-converting enzyme (ACE) inhibitors, furosemide, fluconazole, lithium, corticosteroids, and warfarin
研究组 & 干预措施
A Placebo or Celebrex
either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks
干预措施: Celebrex (Drug)
B Placebo or Celebrex
either placebo PO BID for the last eight weeks or Celebrex 200 mg PO BID for the last eight weeks
干预措施: placebo (Drug)
结局指标
主要结局
Change in Crohn's Disease Activity Index (CDAI) Scores in Response to Treatment
时间窗: completion of all study participants
Change in Crohn's Disease Activity Index (CDAI) scores in response to treatment
次要结局
- Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Scores in Response to Treatment(completion of all study participants)