Chronic ConstipationPhase 4NCT06989268
Effect to Linaclotide on Colonic Motility
A Phase 4 study testing Linaclotide 290 micrograms in people with Chronic Constipation, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Linaclotide 290 micrograms
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2014to 3 Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years old at the time of consent
Who cannot join
- 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
About this study
Official title: A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY ASSESSED WITH INTRALUMINAL COLONIC MANOMETRY IN HEALTHY SUBJECTS
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.
Read the detailed description
Rationale: Several treatments with different modes of action are currently available for chronic constipation, including the osmotic laxative polyethylene glycol (PEG), the stimulant laxative bisacodyl, the prokinetic prucalopride and the secretagogue linaclotide. In a previous study conducted in our lab (study S54750) it has been hypothesized that only bisacodyl and prucalopride activate colonic motility. However the results have demonstrated that PEG, bisacodyl and prucalopride did not differ in their effect on colonic motility index, except for bisacodyl which induced HAPCs in a greater number of healthy subjects as compared to both prucalopride and PEG. To our knowledge, the effect of linaclotide on colonic motility has never been studied in humans.
Objectives: Primary: to evaluate the effects of linaclotide as 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: 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.
Investigational product, dose, and mode of administration: Regimen A: 290 μg linaclotide once daily oral administration with 125mL of water. Regimen B: placebo, empty capsule, once daily oral administration with 125mL of water.
Methodology: This is randomized, placebo controlled, 2-period cross-over study investigating the effects of placebo and linaclotide on colon motility with intraluminal manometry. On each of Treatment Period, a manometry catheter will be placed in the colon under conscious sedation and the colonic pressure will be continuously measured through 8 hours after administration of each of the investigational products (Regimen A or B).
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.
- Conditions
- Chronic Constipation
- Being tested
- Linaclotide 290 micrograms, Placebo
- Keywords
- laxatives, constipation, linaclotide
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linaclotide 290 microgramsDrug
290 μg linaclotide once daily oral administration with 125mL of water
PlaceboDrug
Placebo, empty capsule, once daily oral administration with 125mL of water
| Study group | Role | What they receive |
|---|---|---|
| Linaclotide | Active comparator | 290 μg linaclotide once daily oral administration with 125mL of water Receives: Drug: Linaclotide 290 micrograms |
| Placebo | Placebo comparator | placebo, empty capsule, once daily oral administration with 125mL of water Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic motor patterns during Linaclotide or Placebo administration in healthy subjects.
Number of colonic high amplitude propagated contractions (HAPCs)
Measured: during a 12-hour intraluminal manometry]
Secondary outcomes (1)
Association between motility parameters and number and consistency of bowel movements in healthy subjects
Number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart
Measured: during a 12-hour intraluminal manometry]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start10 Feb 2014
- Primary completion15 Feb 2015
- Study completion3 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ConstipationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Open-label, randomized, reader-blinded, 2-period cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989268
- Sponsor's protocol ID
- S56101
- Status last verified
- Sep 2024
- First submitted
- 16 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMISED, PLACEBO-CONTROLLED, CROSSOVER STUDY TO EVALUATE THE EFFECT OF LINACLOTIDE ON COLONIC MOTILITY ASSESSED WITH INTRALUMINAL COLONIC MANOMETRY IN HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT06989268
- Acronym / sponsor ID
- S56101
- Conditions
- Chronic Constipation
- Keywords
- laxatives, constipation, linaclotide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Feb 2014 (actual)
- Primary completion
- 15 Feb 2015 (actual)
- Study completion
- 3 Jun 2015 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Several treatments with different modes of action are currently available for chronic constipation, including the osmotic laxative polyethylene glycol (PEG), the stimulant laxative bisacodyl, the prokinetic prucalopride and the secretagogue linaclotide. In a previous study conducted in our lab (study S54750) it has been hypothesized that only bisacodyl and prucalopride activate colonic motility. However the results have demonstrated that PEG, bisacodyl and prucalopride did not differ in their effect on colonic motility index, except for bisacodyl which induced HAPCs in a greater number of healthy subjects as compared to both prucalopride and PEG. To our knowledge, the effect of linaclotide on colonic motility has never been studied in humans.
Objectives: Primary: to evaluate the effects of linaclotide as 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: 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.
Investigational product, dose, and mode of administration: Regimen A: 290 μg linaclotide once daily oral administration with 125mL of water. Regimen B: placebo, empty capsule, once daily oral administration with 125mL of water.
Methodology: This is randomized, placebo controlled, 2-period cross-over study investigating the effects of placebo and linaclotide on colon motility with intraluminal manometry. On each of Treatment Period, a manometry catheter will be placed in the colon under conscious sedation and the colonic pressure will be continuously measured through 8 hours after administration of each of the investigational products (Regimen A or B).
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, randomized, reader-blinded, 2-period cross-over study
| Arm | Type | Receives |
|---|---|---|
| Linaclotide | Active comparator | Drug: Linaclotide 290 micrograms290 μg linaclotide once daily oral administration with 125mL of water |
| Placebo | Placebo comparator | Drug: Placeboplacebo, empty capsule, once daily oral administration with 125mL of water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years old at the time of consent
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linaclotide 290 micrograms290 μg linaclotide once daily oral administration with 125mL of water | Drug | Linaclotide |
| PlaceboPlacebo, empty capsule, once daily oral administration with 125mL of water | Drug | Placebo |
Primary outcome
Colonic motor patterns during Linaclotide or Placebo administration in healthy subjects.
Time frame: during a 12-hour intraluminal manometry]
Number of colonic high amplitude propagated contractions (HAPCs)
1 secondary outcome
Association between motility parameters and number and consistency of bowel movements in healthy subjects
Time frame: during a 12-hour intraluminal manometry]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linaclotide 290 micrograms in people with Chronic Constipation, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic motor patterns during Linaclotide or Placebo administration in healthy subjects. (time frame: during a 12-hour intraluminal manometry]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.