DO CONTRACTIONS INVOLVING THE ENTIRE COLON HAVE A ROLE IN THE GENESIS OF CHRONIC CONSTIPATION?

IS THE ABSENCE OF PAN-COLONIC PRESSURIZATIONS A RELEVANT PATHOPHYSIOLOGICAL MECHANISM IN A SUBGROUP OF PATIENTS WITH CHRONIC IDIOPHATIC CONSTIPATION? - ROLE OF PANCOLONIC CONTRACTIONS IN CHRONIC CONSTIPATION

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001384-12-BE

Enrollment

Registered

2014-05-14

Start date

2014-07-16

Completion date

Unknown

Last updated

2021-03-08

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

Conditions

COLONIC MOTILITY WILL BE STUDIED BOTH IN HEALTHY SUBJECTS AND IN PATIENTS WITH CHRONIC CONSTIPATION

Interventions

Trade Name: Prostigmine Product Name: Prostigmine Pharmaceutical Form: Solution for injection INN or Proposed INN: NEOSTIGMINE METILSULFATE CAS Number: 51-60-5 Current Sponsor code: prostigmine 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. Patients will be 40 male and non-pregnant, non-breastfeeding female participants, aged 18–65 years old at the time of consent with chronic constipation as defined by Rome III criteria. 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 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: use of medications within 48 h of dose initiation; structural or metabolic diseases that affect the gastrointestinal system and functional gastrointestinal disorders (other than chronic constipation for patients); previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; use of agents 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: The aim of the project will be to further characterize these pan-colonic events to clarify whether they can play a role in the pathophysiology of chronic constipation. We want to address the following specific objectives: 1) the effect of cholinergic modulation on the frequency and characteristics of these pan-colonic events (amplitude, duration, associated anal sphincter relaxation) in healthy subjects and 2) whether absence or different characteristics of these events could help to clarify the pathophysiology of chronic constipation studying the frequency and characteristics of these pan-colonic events in patients with chronic constipation.;Secondary Objective: not applicable;Primary end point(s): evaluation of the frequency and characteristics (amplitude, duration) of pan-colonic pressurizations associated with anal sphincter relaxations.;Timepoint(s) of evaluation of this end point: end of the trial	—

Measure

Time frame

Main Objective: The aim of the project will be to further characterize these pan-colonic events to clarify whether they can play a role in the pathophysiology of chronic constipation. We want to address the following specific objectives: 1) the effect of cholinergic modulation on the frequency and characteristics of these pan-colonic events (amplitude, duration, associated anal sphincter relaxation) in healthy subjects and 2) whether absence or different characteristics of these events could help to clarify the pathophysiology of chronic constipation studying the frequency and characteristics of these pan-colonic events in patients with chronic constipation.;Secondary Objective: not applicable;Primary end point(s): evaluation of the frequency and characteristics (amplitude, duration) of pan-colonic pressurizations associated with anal sphincter relaxations.;Timepoint(s) of evaluation of this end point: end of the trial

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactMaura Corsetti

KULEUVEN

maura.corsetti@med.kuleuven.be0032016330147

Outcome results

None listed

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