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

Ferring International Pharmascience Center US, Inc.0 个研究点目标入组 411 人开始时间: 2013年4月4日最近更新: 2015年7月10日

研究概览

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•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 274
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 137

•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 The patient has been withdrawn/discontinued from the 000079 or 000080 trials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 (IUS).
•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

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