EUCTR2012-005601-46-BE进行中（未招募）不适用
A Multicenter, Open-label, Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation - Echo 3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 900
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 has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080
- •2. The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments
- •3. 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 300
排除标准
- •1. The patient has been withdrawn/discontinued from the 000079 or 000080 trials
- •2. The patient is not willing to abide by the restrictions for intake of prohibited medication
- •3. Women of childbearing potential (defined, for the purpose of this trial,
- •as all females post-puberty, not postmenopausal =2 years, or not
- •surgically sterile) who have a positive urine pregnancy test at Visit 1, or
- •do not agree to use one of the following methods of birth control from
- •the day of signing the ICF until 30 days after the final dose of trial drug
- •are excluded:
- •a. Transdermal patch.
- •b. Established use of oral, injected or implanted hormonal methods of
- •contraception.
- •c. Placement of an intrauterine device (IUD) or intrauterine system
- •d. Barrier methods of contraception: Condom or Occlusive cap
- •(diaphragm or cervical/vault caps) with spermicidal
- •foam/gel/film/cream/suppository.
- •e. Male sterilisation (with the appropriate post-vasectomy
- •documentation of the absence of sperm in the ejaculate).
- •f. True sexual abstinence: when this is in line with the preferred and
- •usual lifestyle of the patient.
- •4. The patients is considered by the Investigator to be unsuitable to
- •participate in the trial for any other reason
研究者
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