Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
关键词
抽象
日期
最后验证: | 05/31/2020 |
首次提交: | 06/28/2020 |
提交的预估入学人数: | 06/28/2020 |
首次发布: | 07/01/2020 |
上次提交的更新: | 06/28/2020 |
最近更新发布: | 07/01/2020 |
实际学习开始日期: | 07/31/2020 |
预计主要完成日期: | 07/31/2022 |
预计完成日期: | 02/28/2023 |
状况或疾病
干预/治疗
Drug: Ranolazine
Drug: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Ranolazine, Then Placebo - 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 | |
Experimental: Placebo, Then Ranolazine - 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 |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, diltiazem, verapamil, erythromycin, fluconazole, grapefruit juice or grapefruit-containing products, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's Wort. - Concurrent use of statin medications, Digoxine, TCA antidepressants or anti-psychotics, or metformin - Concurrent use of OCT2 substrates - Concurrent use of drugs transported by P-gp or drugs metabolized by CYP2D6 - Concurrent use of drugs known to prolong the QT interval - 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) |
结果
主要结果指标
1. Mean change in daily number of loose stools from baseline [Baseline to Week 36]
次要成果指标
1. Mean change in Crohn's Disease Activity Index (CDAI) score [Baseline to Week 36]
2. Mean change in Harvey Bradshaw Index (HBI) score [Baseline to Week 36]
3. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) score [Baseline, Day 84, and Day 168]
4. Patient Health Questionnaire (PHQ-9) score [Baseline, Day 84, Day 168]