A STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY

Conditions: COLONIC MOTILITY WILL BE STUDIED IN HEALTHY SUBJECTS
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2013-004939-73-BE

Lead Sponsor: KULEUVE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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