Randomized controlled trial of escitalopram versus placebo for patients with irritable bowel syndrome and panic disorder. - escitalopram trial

MUMC0 sites80 target enrollmentJune 17, 2010

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2010

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•IBS will be diagnosed according to the Rome III criteria1 \*:
•Recurrent abdominal pain or discomfort at least 3 days per month in the last 3
•months associated with 2 or more of the following:
•Improvement with defecation.
•Onset associated with a change in frequency of stool.
•Onset associated with a change in form (appearance) of stool.
•\*Criteria have to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
•\*Discomfort means an uncomfortable sensation not described as pain. In pathophysiological research and clinical trials, a pain/discomfort frequency of at least 2 days a week during screening evaluation is an indication for subject’s eligibility.
•2\) Subtyping of IBS patients will be performed using the following classification
•according tot the Rome III criteria: IBS with constipation (IBS\-C), IBS

•1\) Inability to stop medication that can influence gastrointestinal motility or perception
•(like loperamide, butylscopolamine, duspatal, metoclopramide, domperidon,
•erytromycine), serotonin metabolism (like carbidopa, food supplementation), or
•epigenitics (like valproic acid), or containing Sint\-Janskruid (Hypericum perforatum).
•2\) Administration of investigational drugs in the 180 days prior to the study.
•3\) Major abdominal surgery interfering with gastrointestinal function (uncomplicated
•appendectomy, cholecystectomy and hysterectomy allowed, and other surgery
•upon judgement of the principle investigator), epilepsy or (hypo)manic episodes.
•4\) Pregnancy and lactation.
•5\) Excessive alcohol consumption (\>20 alcoholic consumption per week) or drug