NCT00126373已完成2 期
A Randomized Controlled Trial of Wellbutrin for Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks
研究概览
简要总结
The investigators are testing the hypothesis that Wellbutrin (bupropion) can give a clinical remission in Crohn's disease.
详细描述
Wellbutrin (bupropion) is approved for use as an antidepressant. There have been some cases in which people on Wellbutrin had significant improvement clinically in their Crohn's disease. In this trial, the hypothesis that Wellbutrin can induce clinical remission in Crohn's disease will be tested. The investigators will also be looking to see if Wellbutrin can lower levels of the inflammatory cytokine tumor necrosis factor-alpha (TNF).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe Crohn's disease with 220 < CDAI <
- •All patients in the study must have not had any anti-TNF antibodies for at least eight weeks.
排除标准
- •Patients will be excluded from the study if they have fulminant Crohn's disease requiring parenteral steroid treatment, hospitalization, or need of surgery imminently.
- •Patients with serious infections in the preceding three months, opportunistic infections within one month, or current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological, or cerebral disease will be excluded.
- •Patients will also be excluded from the study if they have a history of a seizure, epilepsy, presumed current central nervous system tumor, have or have had anorexia nervosa or bulimia, are currently taking or have taken in the last four weeks any drug in the monoamine oxidase inhibitor class, or are allergic to Wellbutrin.
- •Patients with active major depression or suicidal ideation will be excluded, as will patients with a score of 19 or higher on the Beck depression inventory.
- •Patients will be excluded if they are currently or have taken a medicine in the selective serotonin reuptake class, mirtazapine, venlafaxine, a tricyclic antidepressant, a mood stabilizing, or antipsychotic medication in the previous two weeks.
- •Patients will be excluded if they are currently abusing alcohol or have alcohol dependence.
- •Patients will be excluded from the study if their baseline liver function tests are greater than twice the upper limit of normal, or if a clinical investigator believes that their baseline chemistry, liver function tests or complete blood count contraindicates entry into the study.
- •Pregnant or lactating females are excluded.
研究组 & 干预措施
Sugar pill
Placebo Comparator
Placebo (sugar) pill with identical look to bupropion
干预措施: Wellbutrin (bupropion) (Drug)
buproprion
Experimental
bupropion pill
干预措施: Wellbutrin (bupropion) (Drug)
结局指标
主要结局
Number of patients with Crohn's disease activity index (CDAI) < 150 at the end of twelve weeks
时间窗: 0, 2, 4, 8, 12 weeks
次要结局
- Number of patients with CDAI drop of at least 70 points at the end of twelve weeks(0, 12 weeks)
- Effect of drug and/or placebo on tumor necrosis factor-alpha (TNF) levels(0, 12 weeks)
- Time course of CDAI(0, 2, 4, 8, 12 weeks)
研究者
研究点 (2)
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