EUCTR2018-004419-32-PL进行中（未招募）1 期
A Phase IIa, Proof of Concept, Randomized, Double-Blind, Dose-Finding, Cross-Over Study of the Efficacy, Safety and Tolerability of a New Enteric-Coated Cholestyramine Capsule in Adult Short Bowel Syndrome Patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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. Adult, ambulatory male and female subjects
- •2. Provision of signed and dated informed consent form (ICF)
- •3. Age = 18 years and = 80 years
- •4. Stable SBS of:
- •a. Non-surgical origin; OR
- •b. Surgical origin where the last surgical ileal resection was performed at least 6 months prior to enrolment
- •5. Partial, Home Parenteral Nutrition and/or parenteral fluids are allowed, at a maximum frequency of 6 times a week throughout the trial, as long as the regimen has been stable for at least 2 weeks prior to screening and is expected to remain unchanged during the study
- •6. At least 50 % of the colon being intact
- •7. Intact duodenum
- •8. BMI = 18
- •9. Presence of stable chronic diarrhea for at least 3 months prior to enrolment as evidenced by medical history
- •10. Presence of stable chronic diarrhea during the 2-week screening diary period before randomization, as evidenced by completion of a screening diary demonstrating:
- •a. Mean daily production of at least 3 soft or watery stools (BSFS scores 6 or 7); or
- •b. More than 3 bowel movements per day on average with >25% of them being BSFS type 6 or 7
- •11. Stated willingness and ability to comply with all study procedures, including daily recording of bowel movements and BSFS in the patient diaries, and availability for the duration of the study
- •12. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by the investigator
- •13. Female subjects must meet one of the following criteria:
- •a) Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first study treatment administration through to at least 30 days after the last dose of the study treatment. An acceptable method of contraception includes one of the following:
- •a. Abstinence from heterosexual intercourse
- •b. Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- •c. Intrauterine device (with or without hormones)
- •d. Condom with spermicide
- •b) Participants of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy or bilateral oophorectomy) or is in a menopausal state (i.e. at least 1 year without menses prior to the first study drug administration) are eligible
- •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 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Patients with known or suspected intestinal strictures of clinical relevance as judged by the Investigator
- •2. Active inflammatory bowel disease (IBD) or fistula during the screening period as judged by the Investigator
- •3. Crohn's disease patients not being in clinical remission for the last 12 weeks prior to randomization
- •4. Diarrhea caused by other causes than SBS
- •5. Presence of clinically significant steatorrhea, requiring pancreatic enzymes supplementation
- •6. Presence of complete biliary obstruction
- •7. Presence of active cancer (except resected cutaneous basal or squamous cell carcinoma and except in situ cervical cancer) and/or need to receive chemotherapy or radiotherapy during the study
- •8. History of allergic reaction to cholestyramine or any excipient of the investigational drug product or placebo, or packaging components
- •9. Females who are lactating at screening
- •10. Females who are pregnant according to the pregnancy test at screening or prior to the first study treatment administration
- •11. Significant history (at least 3 consecutive months in the year prior to Screening) of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- •12. Subjects who took an Investigational Product (IP) in the 30 days prior to the first study drug administration
- •13. Any other clinically significant condition that is considered by the principal investigator as being susceptible to put the patient at greater safety risk, influence response to study product, or interfere with study assessments.
研究者
相似试验
进行中（未招募）
1 期
A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.EUCTR2017-003228-54-ESPaloBiofarma S.L.30
进行中（未招募）
1 期
MK-7264 Phase 2a in Women with Endometriosis-related PaiModerate to severe Endometriosis-related pain (ERP)MedDRA version: 20.0Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 100000004872EUCTR2018-001098-26-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.187
进行中（未招募）
1 期
MK-7264 Phase 2a in Women with Endometriosis-related PaiModerate to severe Endometriosis-related pain (ERP)MedDRA version: 21.1Level: LLTClassification code 10014788Term: Endometriosis related painSystem Organ Class: 100000004872EUCTR2018-001098-26-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.166
进行中（未招募）
不适用
A Phase II Proof-of-Concept, Randomized, Double-blind, Vehicle-controlled Study, Including an Open-label Comparison to an Active Control, To Assess the Efficacy and Safety/Tolerability of Topical Riluzole in Patients with Stable Plaque-type Psoriasis - BF-37 in stable plaque-type psoriasisEUCTR2007-007037-39-DEBiofrontera Bioscience GmbH
进行中（未招募）
1 期
A phase 2a proof of concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti-TNF therapy (NAMASTE study)moderate-to-severe axial spondyloarthritisMedDRA version: 20.0Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2018-000176-15-GBIzana Bioscience Limited42