A placebo controlled trial with Baclofen for the treatment of patients with clinical suspicion of rumination syndrome or esophageal belching - Effect of baclofen on rumination

ZLeuven0 sites20 target enrollmentAugust 19, 2011

Overview

No summary available.

Registry

who.int

Start Date

August 19, 2011

End Date

June 30, 2016

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ZLeuven

•1\.Patients with clinical suspicion of rumination syndrome or supragastric belching
•2\. 18 to 75 years old.
•3\.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.
•4\.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 20
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\.Systemic diseases, known to affect esophageal motility.
•2\.Surgery in thorax or in the upper part of the abdomen.
•3\.Treatment with baclofen prior to the start of the study.
•4\.Significant neurological, respiratory, hepatic, renal, haematological, cardiovascular, metabolic or gastroinestinal cerebrovascular disease as judged by the investigator
•5\.Pregnancy or breast feeding.
•6\.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\-controlled depression is allowed).
•7\.History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.