INFLUENCE OF THE TYPE AND SITE OF DISTENSION IN THE EVALUATION OF DRUGS EFFICACY IN MODULATING COLON AND RECTAL FUNCTION IN MAN

ROLE OF THE TYPE AND SITE OF DISTENSION IN THE EVALUATION OF DRUGS EFFICACY IN MODULATING THE SENSORY AND MOTOR RESPONSE OF THE DESCENDING COLON AND THE RECTUM IN MAN - INFLUENCE OF THE TYPE AND SITE OF DISTENSION IN THE EVALUATION OF DRUGS EFFICACY IN MODULATING COLON

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002017-28-BE

Enrollment

Registered

2014-05-15

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

HEALTHY SUBJECTS AND PATIENTS WITH IRRITABLE BOWEL SYNDROME

Interventions

Trade Name: CONSTELLA Product Name: Linaclotide Pharmaceutical Form: Capsule, hard INN or Proposed INN: linaclotide CAS Number: 851199-59-2 Current Sponsor code: linaclotide Other descriptive name: LI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Thirteen patients diagnosed with IBS with constipation according to the Rome III criteria, aged 18–65 years at the time of consent, will be recruited. In addition, ten sex- and age-matched healthy controls (male or non-pregnant, non-breastfeeding females) will also be recruited 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 23 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 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: to evaluate the effect of linaclotide versus placebo on colon and rectal sensorimotor responses to barostat-controlled distensions in healthy subjects (objective 1) and to perform the same study in C-IBS patients and compare the results in both groups (objective 2).;Secondary Objective: not applicable;Primary end point(s): Objective 1: thresholds for sensations, tone and distensibility during colonic and rectal distension before and after placebo in healthy subjects. Objective 2: thresholds for sensations, tone and distensibility during colonic and rectal distension before and after placebo in IBS patients and their differences with healthy subjects.;Timepoint(s) of evaluation of this end point: end of the trial	—

Measure

Time frame

Main Objective: to evaluate the effect of linaclotide versus placebo on colon and rectal sensorimotor responses to barostat-controlled distensions in healthy subjects (objective 1) and to perform the same study in C-IBS patients and compare the results in both groups (objective 2).;Secondary Objective: not applicable;Primary end point(s): Objective 1: thresholds for sensations, tone and distensibility during colonic and rectal distension before and after placebo in healthy subjects. Objective 2: thresholds for sensations, tone and distensibility during colonic and rectal distension before and after placebo in IBS patients and their differences with healthy subjects.;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