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10日最近更新: 2015年8月4日

适应症

试验速览

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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 The patient has been withdrawn/discontinued from the 000079 or 000080 trials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.Hormonal contraception (i.e., oral, implant, or injectable contraceptive)
•c. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.)
•d. Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy
•e. Sexual abstinence
•4. The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason

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