EUCTR2012-001600-38-GB进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Furiex Pharmaceuticals0 个研究点目标入组 1,282 人开始时间: 2012年6月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,282
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient is a man or woman aged 18 to 80 years, inclusive, at Prescreening.
- •2. Patient has a diagnosis of IBS with a subtype of diarrhea defined by the Rome III criteria as loose (mushy) or watery stools = 25% and hard or lumpy stools <25% of bowel movements (see Appendix 6.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
- •3. Patient has had a colonoscopy performed:
- •a. Within 10 years prior to Prescreening if patient is at least 50 years of age (alternatively, a flexible sigmoidoscopy, double contrast barium enema, or CT colonography within the past 5 years is acceptable [see recommendations of the American Cancer Society])
- •b. Since the onset (if applicable) of any of the following alarm features for patients of any age (see Spiller and Thompson, 2010):
- •i. Patient has documented weight loss within the past 6 months;
- •ii. Patient has nocturnal symptoms;
- •iii. Patient has a familial history of colon cancer; or
- •iv. Patient has blood mixed with their stool (excluding any blood from hemorrhoids).
- •Note: Patients with any history of alarm features must have documentation within their medical record of the gastrointestinal work up performed.
- •(Refer to protocol for criteria 4 to 12).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •1. Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS by the Rome III criteria (see Appendix 6.2 of the protocol: Rome III Diagnostic Criteria for IBS for a definition of IBS and subtyping by predominant stool pattern).
- •2. Patient has a history of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis) and celiac disease.
- •3. Patient has a history of diverticulitis within 3 months prior to Prescreening.
- •4. Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
- •5. Patient has any of the following surgical history:
- •a. Cholecystectomy with ANY history of post cholecystectomy biliary tract pain. Patients who had a successful cholecystectomy with no post operative biliary tract pain are candidates for the study;
- •b. Any abdominal surgery within the 3 months prior to Prescreening;
- •c. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post surgery are allowed).
- •(Refer to protocol for criteria 6. to 35).
研究者
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