A STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY

A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY ASSESSED WITH INTRALUMINAL COLONIC MANOMETRY IN HEALTHY SUBJECTS - EFFECT OF LINACLOTIDE ON COLONIC MOTILITY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004939-73-BE

Enrollment

Registered

2014-04-04

Start date

2014-05-13

Completion date

Unknown

Last updated

2024-12-16

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 IN HEALTHY SUBJECTS

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: 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 48 h 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 effects of linaclotideas compared to placebo on motility index and on the number of colonic high amplitude propagated contractions (HAPCs) during a 8-hour intraluminal manometry in healthy subjects. ;Secondary Objective: to evaluate the association between motility parameters and sensations (abdominal gas, desire to defecate, urgency to defecate and abdominal discomfort) as well as number and consistency of bowel movements.;Primary end point(s): Motility index during the 8 hours after treatment initiation and number of HAPCs. ;Timepoint(s) of evaluation of this end point: end of the trial	—

Measure

Time frame

Main Objective: to evaluate the effects of linaclotideas compared to placebo on motility index and on the number of colonic high amplitude propagated contractions (HAPCs) during a 8-hour intraluminal manometry in healthy subjects. ;Secondary Objective: to evaluate the association between motility parameters and sensations (abdominal gas, desire to defecate, urgency to defecate and abdominal discomfort) as well as number and consistency of bowel movements.;Primary end point(s): Motility index during the 8 hours after treatment initiation and number of HAPCs. ;Timepoint(s) of evaluation of this end point: end of the trial

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary: Sensations score on visual analogue scales and number and consistency of bowel movements as assessed by the Bristol Stool Scale.;Timepoint(s) of evaluation of this end point: end of the trial	—

Countries

Belgium

Contacts

Public ContactMaura Corsetti

KULEUVEN

maura.corsetti@med.kuleuven.be00320468183222

Outcome results

None listed

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