Effect to Linaclotide on Colonic Motility

NCT06989268 | Completed Phase 4

• 1 other identifier: S56101
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Constipation

Keywords

laxatives; constipation; linaclotide

Outcome Measures

Primary Outcomes (1)

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

  Number of colonic high amplitude propagated contractions (HAPCs)

  during a 12-hour intraluminal manometry]

Secondary Outcomes (1)

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

  during a 12-hour intraluminal manometry]

Study Arms (2)

Linaclotide

ACTIVE COMPARATOR

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

Drug: Linaclotide 290 micrograms

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Linaclotide 290 micrograms DRUG

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

Linaclotide

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years old at the time of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Tack, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, reader-blinded, 2-period cross-over study

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: February 10, 2014
• Primary Completion: February 15, 2015
• Study Completion: June 3, 2015
• Last Updated: May 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share