Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)
关键词
抽象
描述
Irritable bowel syndrome (IBS) is a common gastrointestinal disorder affecting about 20% of the United States population and comprising almost 50% of referrals to gastroenterology practices. Although the pathophysiology of IBS is poorly understood, more recently, both inflammation and an increased intestinal permeability have been identified as potential factors in the etiology of diarrhea-predominant IBS patients(dIBS). Despite the potential of an inflammatory etiology for IBS, few studies have examined the efficacy of anti-inflammatory agents such as mesalamine in patients with IBS. The primary objective of our study is to determine the efficacy of Apriso™ (Salix Pharmaceuticals Inc), a long-acting mesalamine, in the treatment of patients with dIBS. Apriso™, is a mesalamine approved by the Food and Drug Administration (FDA) on October 31, 2008 for the maintenance of remission in patients with active, mild to moderate ulcerative colitis. The investigators will perform a randomized, double-blind, cross-over trial of mesalamine compared to placebo in patients with dIBS. This study will analyze both the objective and subjective measures of improvement in IBS symptoms. The subjective measures will include improvements in the overall symptom severity scores and the Global Improvement Scale (GIS) and the objective measures will include histological measures of inflammation as well as improvements in the intestinal membrane permeability of treated subjects. The investigators will demonstrate that during the 12 weeks treatment period with mesalamine, subjects will have improvements in their overall symptom scores, GIS scores, and will have a reduction in intestinal inflammation and also prohibit a likely improvement in Intestinal membrane permeability.
日期
| 最后验证: | 12/31/2013 |
| 首次提交: | 03/23/2011 |
| 提交的预估入学人数: | 03/30/2011 |
| 首次发布: | 03/31/2011 |
| 上次提交的更新: | 01/14/2014 |
| 最近更新发布: | 02/11/2014 |
| 首次提交结果的日期: | 04/03/2013 |
| 首次提交质量检查结果的日期: | 01/14/2014 |
| 首次发布结果的日期: | 02/11/2014 |
| 实际学习开始日期: | 02/28/2010 |
| 预计主要完成日期: | 02/29/2012 |
| 预计完成日期: | 02/29/2012 |
状况或疾病
干预/治疗
Drug: Mesalamine
Other: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Mesalamine This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm. | Drug: Mesalamine Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm. |
| Placebo Comparator: Placebo This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm. | Other: Placebo 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm. |
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: - Male and female aged 18-65 years old - Functional Bowel Disorder Severity Index Score above 37 - Normal complete blood count, liver function studies and renal function studies - Serologies done to rule out Celiac Spure or patient has prior negative EGD with small bowel biopsies which have been negative - Infectious diarrhea ruled out by stool studies - Negative colonoscopy Exclusion Criteria: - Any history of chronic liver disease, heart disease, pulmonary or renal disease - Abnormal EKG - Women with positive pregnancy tests - Patient on steroids, antacids, or warfarin or chronic pain conditions other than fibromyalgia - Patients who drink over 2oz alcohol/day on a regular basis Any other causes for diarrhea such as IBD, microscopic colitis, celiac disease, history of abdominal obstruction, pancreatitis, ileus, or any gastrointestinal bleeding. - Patients with active malignancy in the past five years - Patient with any history of hypersensitivity reactions to salicylate containing medications due to cross-sensitivity with mesalamine or allergy to mesalamine medications in the past - Any subjects with fibromyalgia will be excluded from the pain testing portion only - History of Phenylketonuria due to the aspartame contained in Apriso |
结果
主要结果指标
1. Changes in GIS Scores Between Baseline and After a 12 Week Intervention With Mesalamine or Placebo [Baseline and at 12 weeks post-intervention]
次要成果指标
1. Number of Participants Who Had Evidence of Increased Levels of Pathologic Indicators of Colonic Mucosal Inflammation at 12 Weeks Compared to Baseline. [For 2 times: First time: at the time of patient recruitment in the study Second time: after the completion of first 12-week treatment period, all of which are during the time period from 02/25/2010 to 02/01/2012 (up to 2 years)]
2. Functional Bowel Disorder Severity Index (FBDSI) [An FBDSI score is administered at the beginning of each 12-week treatment period (baseline) and at the end of each 12-week treatment period.]
3. IBS - Quality of Life (IBS-QOL)Score. [at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)]
4. Hospital Anxiety and Depression Scale (HADS) [at the time of recruitment and after completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)]
5. Intestinal Permeability Testing [At the completion of each 12-week treatment period, all of which are during the time period from 03/25/2010 to 02/01/2012 (up to 2 years)]
