A STUDY TO COMPARE THE EFFECT OF A STIMULANT LAXATIVE (SODIUM PICOSULFATE) AND OF A PROKINETIC DRUG (PRUCALOPRIDE) ON SENSITIVITY AND MOTILITY OF THE LEFT COLON IN HEALTHY SUBJECTS
- Conditions
- SENSORY AND MOTOR RESPONSE OF DESCENDING COLON TO DISTENSION WILL BE STUDIED IN HEALTHY SUBJECTSTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2012-004367-44-BE
- Lead Sponsor
- KU LEUVE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
healthy male and non-pregnant, non-breastfeeding female participants, aged 18–65 years old at the time of consent.
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
use of medications within 48h of dose initiation; structural or metabolic diseases that affect the gastrointestinal system and functional gastrointestinal disorders; previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; use ofagents that influence bowel habit, i.e. anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics and prokinetics in the 7 days before the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to compare and determine the effects of sodium picosulfate, prucalopride and placebo on the sensory thresholds to distension by means of the electronic barostat in healthy subjects. ;Secondary Objective: to evaluate the effect of sodium picosulfate, prucalopride and placebo on the motor response to distension and the influence of these motor responses on the colonic sensory response to distension.;Primary end point(s): thresholds for sensations during colonic distension before and after treatment.;Timepoint(s) of evaluation of this end point: end of the trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): mean tone and motility index (both during tone and distension measurement) before and after treatment and their influence on sensory response to distension. ;Timepoint(s) of evaluation of this end point: end of the trial