CLINICAL TRIAL PHASE IIIb to evaluate predictors of response to linaclotide in patients with irritable bowel syndrome and explore the impact on intestinal symptoms - linaclotide

almirall0 个研究点开始时间: 2013年11月12日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•1. Age betwen 18 and 70 years old
•2. Sex: male and female
•3. Meet the Rome III criteria for the diagnosis of constipation predominant IBS
•4. Moderate-severe constipation IBS, defined as a score greater than 175 points IBSSS
•5. Clinical explorations to support the diagnosis of IBS:
•a. All patients: blood in less than six months that shows no anemia
•b. Over 50 years: colonoscopy to the cecum without abnormalities explaining the symptoms in the last five years.
•6. Sign informed consent: Patients should give informed consent in writing and must be able to read and understand it.
•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 108
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1. Women of childbearing age who are unwilling or unable to use valids methods of contraception during the study period and up to 4 weeks after finishing.
•2. Women of childbearing age who use an invalid method of contraception.
•3. Pregnant or breast-feeding.
•4l. Women with a positive pregnancy test at the time of enrollment or prior to study drug administration.

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