NCT04456517终止2 期
REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Daily Number of Loose Stools
研究概览
简要总结
Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. The purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and other symptoms. Ranolazine is approved by the US Food & Drug Administration (FDA) for chronic angina (a heart condition). This study is investigating if ranolazine could be used in the setting of Crohn's disease.
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
- 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
- •Meet diagnostic criteria for Crohn's Disease with active diarrhea Either with active disease or in remission (as defined by endoscopic or radiographic findings) but experiencing symptoms (e.g., diarrhea, abdominal pain)
- •Have greater than three loose stools per day
排除标准
- •Male and female subjects <18 years of age
- •Significant change in medication including prednisone, antidepressant medications, or stimulants within the last 4 weeks
- •a. Allowances include: Rectal hydrocortisone, rectal mesalamine, addition of prednisone (up to 20mg) for flares, etc.
- •Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
- •Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
- •Previous use of ranolazine within 2 months prior to enrollment
- •Prior use of ranolazine which was discontinued for safety or tolerability
- •Metabolic derangement defined as liver function tests >3x upper limit of normal or severe renal disease defined as calculated creatinine clearance <30 mL/min
- •Have liver cirrhosis
- •Concurrent use of CYP3A inhibitors, inducers, or substrates
- •a. These may include: ketoconazole, itraconazole, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, clarithromycin, or rifampin, rifapentine, phenobarbital, phenytoin, and St. John's Wort, digoxin.
- •A family history of (or congenital) long QT syndrome or known acquired QT interval prolongation
- •Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
- •Patients who are pregnant or breastfeeding
- •Patients who are enrolled in other investigational drug studies or who have taken investigational drugs within 30 days before enrollment
- •Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history) or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)
研究组 & 干预措施
Ranolazine, Then Placebo
Experimental
- Participants first receive a Ranolazine 500 mg tablet twice daily for 12 weeks, they then receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
干预措施: Ranolazine (Drug)
Ranolazine, Then Placebo
Experimental
- Participants first receive a Ranolazine 500 mg tablet twice daily for 12 weeks, they then receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
干预措施: Placebo (Drug)
Placebo, Then Ranolazine
Experimental
- Participants first receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks, they then receive a Ranolazine 500mg tablet twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
干预措施: Ranolazine (Drug)
Placebo, Then Ranolazine
Experimental
- Participants first receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks, they then receive a Ranolazine 500mg tablet twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms
干预措施: Placebo (Drug)
结局指标
主要结局
Daily Number of Loose Stools
时间窗: Baseline to 12 weeks
Daily number of loose stools will be collected directly from all subjects using MyCap.
次要结局
- Crohn's Disease Activity Index (CDAI) Score(Baseline to 12 weeks)
- Harvey Bradshaw Index (HBI) Score(Baseline to Week 12)
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score(Baseline to 12 weeks)
- Patient Health Questionnaire (PHQ-9) Score(Baseline to week 12)
研究者
Dawn Beaulieu
Principle Investigator
Vanderbilt University Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
不适用
A Prospective Trial in Patients With Crohn's Disease in Remission and Having Irritable Bowel Syndrome-like SymptomsIrritable Bowel Syndrome-like SymptomsCrohn Disease RemissionNCT06104631Biokuris s.a.50
终止
2 期
A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseNCT05068284AbbVie176
撤回
2 期
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's DiseaseCrohns DiseaseCrohn's DiseaseNCT04151225GlaxoSmithKline
进行中（未招募）
3 期
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)Crohn's Disease (CD)NCT04524611AbbVie527
已完成
2 期
Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's DiseaseCrohn's DiseaseNCT02048618Galapagos NV175