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

A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO COMPARE THE EFFECT OF SODIUM PICOSULFATE AND PRUCALOPRIDE ON COLONIC SENSORY AND MOTOR RESPONSE TO DISTENSION IN HEALTHY SUBJECTS - EFFECT OF LAXATIVES AND PRUCALOPRIDE ON COLONIC SENSITIVITY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004367-44-BE

Enrollment

Registered

2013-02-15

Start date

2013-05-28

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SENSORY AND MOTOR RESPONSE OF DESCENDING COLON TO DISTENSION WILL BE STUDIED IN HEALTHY SUBJECTS

Interventions

Trade Name: GUTTALAX Product Name: SODIUM PICOSULFATE Pharmaceutical Form: Tablet INN or Proposed INN: SODIUM PICOSULFATE CAS Number: 10040-45-6 Concentration unit: 1X 100 milligrams/millilitre Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Belgium

Contacts

Public ContactJan Tack

KULEUVEN

jan.tack@med.kuleuven.be0032016330147

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026