A placebo controlled trial with Baclofen for the treatment of GERD patients with incomplete PPI response

Zleuven0 个研究点开始时间: 2009年12月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.18 to 75 years old.
•2.History of GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
•3.Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (2*20mg of omeprazole or equivalent).
•4.Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
•5.Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Endoscopic signs of severe erosive esophagitis (= grade C, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
•2.Systemic diseases, known to affect esophageal motility.
•3.Surgery in thorax or in the upper part of the abdomen.
•4.Treatment with baclofen prior to the start of the study.
•5.Regular use of medications such as: anticholinergics, tricycle antidepressants.
•6.Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
•7.Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
•8.Pregnancy or breast feeding.
•9.History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. (well-compensated depression is allowed).
•10.History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

发起方

Zleuven