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Trial · Interventional

CompletedPhase 4Registry data

Effect to Linaclotide on Colonic Motility

NCTNCT06989268 (opens ClinicalTrials.gov in a new tab)Other idS56101
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
10 participants (actual)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
Design
Randomized · Triple masking
Countries
Not stated
Start
10 Feb 2014
Primary completion
15 Feb 2015
Completion
3 Jun 2015
First posted
25 May 2025
Last update posted
25 May 2025
Conditions
Chronic Constipation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 4

    Effect to Linaclotide on Colonic Motility

    NCT06989268

    10 Feb 2014 to 3 Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study aim was to evaluate the effect of Linaclotide, a pharmacological treatment normally used to treat functional constipation or irritable bowel syndrome with predominant constipation, on colonic motility as assessed by high-resolution colonic manometry.

Interventions

  • Linaclotide 290 microgramsDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Linaclotide

    290 μg linaclotide once daily oral administration with 125mL of water

  • Placebo comparator

    Placebo

    placebo, empty capsule, once daily oral administration with 125mL of water

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Colonic motor patterns during Linaclotide or Placebo administration in healthy subjects.

    Time frame · during a 12-hour intraluminal manometry]

    Registry description

    Number of colonic high amplitude propagated contractions (HAPCs)

Secondary outcomes(1)

  1. Association between motility parameters and number and consistency of bowel movements in healthy subjects

    Time frame · during a 12-hour intraluminal manometry]

    Registry description

    Number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years old at the time of consent 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

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