EUCTR2012-005588-28-DE进行中（未招募）不适用
A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial in Patients with Chronic Idiopathic Constipation to Demonstrate the Efficacy and Safety of Elobixibat 5 mg and 10 mg for 12 Weeks Followed by a 4-week Withdrawal Period - Echo 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 840
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
- 性别
- All
入选标准
- •1.The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments
- •2.The patient is a male or female =18 years of age
- •3.The patient has a body mass index (BMI) =18.5 but <35.0
- •4.The patient is ambulatory and community dwelling
- •5.The patient meets modified Rome III criteria: reports <3 spontaneous BM (SBM; defined as a BM occurring in the absence of any laxative intake in the form of a tablet, a suppository or an enema during the preceding 24 hours) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative e.g. tegaserod, lubiprostone, linaclotide, polyethylene glycol 3350, prucalopride:
- •a.Straining during at least 25% of defecations
- •b.Lumpy or hard stools during at least 25% of defecations
- •c.Sensation of incomplete evacuation during at least 25% of defecations
- •6.The patient reports an average of <3 complete SBMs (CSBMs; defined as an SBM associated with a sense of complete evacuation) and =6 SBMs per week by the PDA during the most recent 14 full days before the randomisation visit
- •7.An initial colonoscopy is required if this is recommended according to national guidelines. If no national guidelines are available, a colonoscopy is performed if recommended according to modified American College of Gastroenterology Guidelines for Colorectal Cancer Screening
- •8.The patient is compliant with PDA by having adequately responded to the PDA questions on =10 of the most recent 14 full days before the randomisation visit, recording BMs, stool consistency, and gastrointestinal (GI) symptoms (pain, straining, and discomfort)
- •9.The patient agrees to refrain from making any new, major life-style changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1.The patient reports loose (mushy) or watery stools (Bristol Stool Form Scale [BSFS] score of 6 or 7) in the absence of any laxative intake in the form of a tablet, a suppository or an enema, or prohibited medicine for >25% of BMs during the 12 weeks prior to the Screening Visit
- •2.The patient reports a BSFS of 6 or 7 on any day during the Pretreatment Period, unless this occurred within 24 hours of having taken rescue medication.
- •3.The patient has irritable bowel syndrome (IBS) with pain/discomfort as predominant symptoms as defined by the Rome III criteria: reports abdominal discomfort or pain that has two or more of the following three features the last 3 months with symptom onset at least 6 months before the Screening Visit:
- •a.Improvement with defecation
- •b.Onset associated with a change in frequency of stool
- •c.Onset associated with a change in form (appearance) of stool
- •4.The patient has a structural abnormality of the GI tract or a disease or condition that can affect GI motility.
- •5. The patient has a history of any gastro-intestinal disease not considered to be CIC.
研究者
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